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General Atomics Electromagnetic Systems (GA-EMS) is a supplier of advanced electromagnetic systems, related power equipment and other high technology products for a variety of government and commercial applications. These include products such as the design and fabrication of linear motors, superconducting and conventional rotating motors, power inverters, high-energy capacitors, radiation monitoring systems, high-voltage direct current power distribution systems, and numerous other products. Under general supervision, this position is responsible for developing, analyzing and reporting on quality plans, programs and discrepancies related to assembly, process, mechanical, electrical and electro-mechanical systems. Investigates problems and develops corrective action plans for quality system discrepancies. Ensures that quality performance and records conform to established company and regulatory standards. Interfaces with manufacturing, engineering, customers, vendors and subcontractor representatives to ensure requirements are met. May support calibration program, safety program, records center, and other Quality department administrative activities. DUTIES AND RESPONSIBILITIES: Reviews quality records and data on various elements of the company's Quality Management System to ensure compliance, determine trends, and analyze root cause (ex: travelers, nonconformance reports, corrective actions, inspection results, configuration logs, training records). Coordinates with responsible personnel and supervisors to develop or obtain corrective action plans. Prepares summary reports, charts, and statistical analysis as required. Plans, coordinates, and leads internal audits and surveillance activities of the company's Quality Management System, including interviews, observations, and review of manufacturing, inspection, and test operations and records on shop floor. Creates summary reports and reviews results with management. Conducts opening and closing meetings with responsible management for areas being audited. Supports Quality department administration, develops databases, prepares reports. May supervise records center operations, train and oversee department assistants to review quality records for incomplete operations and errors. Provides training and coordinates with responsible personnel and supervisors to get records corrected, prevent recurrence, and improve processes. Responsible for observing all laws, regulations and other applicable obligations wherever and whenever business is conducted on behalf of the Company. Expected to work in a safe manner in accordance with established operating procedures and practices. Other duties as assigned or required. We recognize and appreciate the value and contributions of individuals with diverse backgrounds and experiences and welcome all qualified individuals to apply. 52162 Job Qualifications: Typically requires a Bachelors degree in Manufacturing Technology, Mathematics or related field along with three or more years experience working as a quality analyst in a manufacturing environment. May substitute additional experience as a quality analyst in lieu of education. Requires a general understanding of quality procedures and system requirements in a manufacturing environment as well as general knowledge of quality concepts and principles including the ability to read and understand engineering drawings and specifications; the ability to identify and interpret data; the ability to prepare detailed statistical reports and documents; interpersonal, verbal and written communication skills to explain general information effectively with all levels of employees; organization skills to maintain flow of work within the unit; the ability to establish priorities; and general knowledge of computer operations and applications and word processing and spreadsheets. Must be customer focused and able to work on a self-initiated basis or in a team environment and able to work extended hours and travel as required. Salary:$62,510 - $105,628Travel Percentage Required 0 - 25Relocation Assistance Provided Not Provided US Citizenship Required? YesClearance Required? No Clearance LevelMid-Level (3-7 years) WorkstyleOnsite
L3Harris is dedicated to recruiting and developing high-performing talent who are passionate about what they do. Our employees are unified in a shared dedication to our customers’ mission and quest for professional growth. L3Harris provides an inclusive, engaging environment designed to empower employees and promote work-life success. Fundamental to our culture is an unwavering focus on values, dedication to our communities, and commitment to excellence in everything we do. L3Harris Technologies is the Trusted Disruptor in the defense industry. With customers’ mission-critical needs always in mind, our employees deliver end-to-end technology solutions connecting the space, air, land, sea and cyber domains in the interest of national security. Job Title: Quality Eng. Technician E Job Code: 31001 Job Location: Carlsbad California Job Schedule: 9/80 Job Description: Quality Eng. Technician E Ensures that products and services meet company standards and end-user requirements by analyzing and solving product conformance problems. Performs quality planning tasks to ensure product conformance to requirements, including preparation of control plans and instructions, sampling plans, procedures and quality records. This position is integrated into Product inspection, manufacturing and test operations to collaborate in a cross-functional environment to address issues and prevent recurrences of issues. Analyzes quality costs and other quality data. Helps to develop tools to facilitate efficient execution of quality planning, verification and analytical processes. Develops and maintains procedures and work instructions relevant to the quality organization. Essential Functions: Inspection of products and their associated documents in accordance with L3Harris Workmanship Standards, engineering requirements, customer specifications, work instructions, inspection plans, and other requirements as needed. Hands on experience using gages such as microscopes, calipers, micrometers, thread gages, height gages, scales, and other measuring equipment as needed Provides internal communication regarding acceptance testing issues. Interfaces with test, manufacturing, engineering, production inspection and customers as needed Carries out projects to reduce Touch Time, defects, and Cycle time. Familiar with the handling and disposition of Nonconforming Material Able to apply basic elements of process control; determines what data to collect for a specific technique, how to apply it to practical business processes, how to analyze data for actionable business intelligence Recommend opportunities for continuous improvement of the processes and products, to include providing support to inspectors working CI projects Understand and able to apply the elements of corrective and preventive actions, including root cause analysis, failure mode and effects analysis (FMEA), and the control of nonconforming material Help to create new processes, tools, and methods to support achievement of quality objectives Train and mentor inspectors on inspection techniques and tools Draft and revise procedures, work instructions and Control Plans Working knowledge and understanding of AS9100/ISO 9001 quality systems Qualifications: (refer to Career Framework) Proficient use of MS Office Suite Good written and oral communication skills with the ability to interface across the organization to achieve effective results Able to perform Inspection of products and associated documents in accordance with L3Harris Workmanship Standards, engineering requirements, customer specifications, work instructions, inspection plans, and other requirements as needed Experience working in a team environment to solve problems and balance workloads Experience with electronic workmanship standards such as IPC-A-610 and IPC-A-620 Experience in Aerospace manufacturing, mechanical assemblies, and/or electronic assemblies Experience with Project Management, Lean tools and Six Sigma principles Preferred Additional Skills: Proficient in SAP Proven experience in collaborative problem-solving and workload balance within a team environment. Certification in electronic workmanship standards such as IPC-A-610 and IPC-A-620. Background in Aerospace manufacturing, mechanical assemblies, and/or electronic assemblies. Experience in corrective and preventive actions, including root cause analysis, failure mode and effects analysis (FMEA), and the control of nonconforming material Experience in writing and developing procedures, work instructions and Control Plans Working knowledge and understanding of AS9100/ISO 9001 quality systems Experience with quality systems from the front end to the backend of the process Salary Range- 87,000.00 - 162,000.00 L3Harris Technologies is proud to be an Equal Opportunity Employer. L3Harris is committed to treating all employees and applicants for employment with respect and dignity and maintaining a workplace that is free from unlawful discrimination. All applicants will be considered for employment without regard to race, color, religion, age, national origin, ancestry, ethnicity, gender (including pregnancy, childbirth, breastfeeding or other related medical conditions), gender identity, gender expression, sexual orientation, marital status, veteran status, disability, genetic information, citizenship status, characteristic or membership in any other group protected by federal, state or local laws. L3Harris maintains a drug-free workplace and performs pre-employment substance abuse testing and background checks, where permitted by law. Please be aware many of our positions require the ability to obtain a security clearance. Security clearances may only be granted to U.S. citizens. In addition, applicants who accept a conditional offer of employment may be subject to government security investigation(s) and must meet eligibility requirements for access to classified information. By submitting your resume for this position, you understand and agree that L3Harris Technologies may share your resume, as well as any other related personal information or documentation you provide, with its subsidiaries and affiliated companies for the purpose of considering you for other available positions. L3Harris Technologies is an E-Verify Employer. Please click here for the E-Verify Poster in English or Spanish. For information regarding your Right To Work, please click here for English or Spanish.
*Quality Control Analyst II* *Location:* Carlsbad, California *Schedule:* Full-Time, On-Site (Monday–Friday) *Compensation:* $75,900 – $86,200 annually + discretionary bonus *Play a Critical Role in Ensuring Diagnostic Accuracy* Lumos Diagnostics develops rapid, point-of-care diagnostic solutions that improve clinical decision support. The Quality Control Analyst II ensures the accuracy, reliability, and consistency of our products through hands-on testing, meticulous documentation, and strict adherence to regulatory standards. This is not an entry-level position. We are seeking a QC professional with proven experience in a regulated manufacturing environment who meets all minimum qualifications listed below. This role is ideal for someone who enjoys hands-on lab work, analytical testing, and quality problem-solving in a fast-paced, ISO 13485 environment. *About the Role* As a QC Analyst II, you will perform in-process, release, and stability testing to support production and ensure product quality. You will execute testing protocols, analyze data, document results with accuracy, and collaborate with cross-functional teams to address trends, deviations, and non-conformances. This position requires exceptional attention to detail, strong documentation skills, and the ability to consistently follow SOPs, quality standards, and regulatory requirements. *What You’ll Do* * Perform hands-on physical, visual, functional, and analytical testing for in-process materials, finished goods, and stability samples * Execute testing in accordance with SOPs, cGMP, and ISO 13485, ensuring compliance and data integrity * Inspect, document, and verify materials and components against established specifications * Support investigations by identifying root causes, documenting non-conformances, and contributing to corrective actions * Review QC batch records, test results, and data for accuracy and completeness * Perform routine equipment verification, calibration checks, and maintenance activities * Assist with sampling plans, trend analysis, quality metrics, and reporting * Support internal and external audit preparation and participate in audit activities * Communicate discrepancies, risks, or process concerns to QC leadership and cross-functional partners *Minimum Qualifications (Required — Must Meet All)* * Bachelor’s degree OR equivalent relevant experience in a scientific or technical field * 2–4 years of experience in QC or laboratory testing in a regulated manufacturing environment (medical device, diagnostics, biotech, or life sciences) * Hands-on experience performing QC testing under cGMP, GLP, or ISO 13485 * Experience documenting non-conformances, deviations, or quality issues * Strong understanding of quality standards such as ISO 13485, ISO 9001, or FDA QSR * Proficiency in following SOPs, completing batch records, and maintaining accurate documentation * Hands-on lab experience performing tests such as pH, visual inspection, functional testing, or physical measurements * Ability to analyze data, identify trends, and communicate findings clearly * Ability to work on-site in Carlsbad, CA *Preferred Qualifications* * Experience with stability studies, quality trending, or complaint evaluations * Experience supporting CAPA investigations * Experience preparing for audits (internal/external) * Familiarity with LIMS, eQMS, or similar systems * ASQ certifications such as CQI or CQA *What We Offer* * Competitive salary and discretionary bonus * Comprehensive health and wellness benefits * 401(k) with company match * 3 weeks vacation, 9 sick days, 1 floating holiday, and 10 paid holidays * Benefits begin the first of the month following hire * Mission-driven environment aligned with our core values: Take Ownership, Engage Openly, Act with Integrity, Move Together *Application Requirement* To be considered for this opportunity, all screening questions must be answered in full. Incomplete applications will not be reviewed. Pay: $75,900.00 - $86,200.00 per year Benefits: * 401(k) matching * Dental insurance * Disability insurance * Employee assistance program * Employee discount * Flexible schedule * Flexible spending account * Health insurance * Health savings account * Life insurance * On-the-job training * Paid jury duty * Paid time off * Parental leave * Professional development assistance * Referral program * Tuition reimbursement * Vision insurance Application Question(s): * This role is 100% on-site in Carlsbad, CA (Monday–Friday). Are you able to work on-site every day? * The compensation range is $75,900–$86,200 annually. Are you comfortable with this range? * Do you have at least 2 years of QC or analytical testing experience in a regulated manufacturing environment (such as medical device, diagnostics, biotech, or life sciences)? * Have you performed quality control testing under cGMP, GLP, or ISO 13485 conditions? * Have you performed in-process, release, or stability testing as part of your QC role? * Have you documented non-conformances, deviations, or related quality reports in a regulated environment? * Do you have working knowledge of ISO 13485, ISO 9001, or FDA Quality System Regulations (QSR)? * Are you experienced performing hands-on analytical tests such as pH, visual inspection, functional checks, or physical measurements? * Are you able to follow SOPs, complete batch records, and document all results with accuracy and compliance? * Do you have experience with data analysis, trending results, or interpreting quality metrics? * Have you worked cross-functionally with departments such as Quality Assurance, Manufacturing, or Supply Chain to troubleshoot or resolve quality issues? Education: * Bachelor's (Required) Work Location: In person
*Manufacturing Chemist II* *Location:* Carlsbad, California *Schedule:* Full-Time, On-Site (Monday–Friday) *Compensation:* $79,200 – $89,400 annually *Advance Diagnostics That Make a Real Impact* Lumos Diagnostics develops point-of-care diagnostic solutions that deliver rapid, actionable results. As a Manufacturing Chemist II, you will play a critical, technical role in developing, optimizing, and transferring reagent formulations that directly impact product quality and patient outcomes. This is not an entry-level position. We are looking for a Chemist with proven, hands-on formulation experience in a regulated diagnostic, medical device, or life sciences environment who meets all minimum qualifications listed below. If you enjoy hands-on lab work, complex troubleshooting, and building robust formulations that transfer successfully into manufacturing, this role is for you. *About the Role* As a Manufacturing Chemist II, you will prepare and optimize reagent, buffer, and solution formulations; perform analytical testing; and support scale-up and transfer activities from bench to production. You will apply scientific judgment, data analysis, and problem-solving skills to ensure formulations are stable, reproducible, and compliant with ISO 13485 and cGMP standards. This role is highly hands-on, working in both the laboratory and production environments to support efficient, high-quality manufacturing. *What You’ll Do* * Develop and optimize reagent, buffer, and solution formulations for diagnostic products * Prepare bench- and manufacturing-scale batches with accuracy and attention to detail * Perform analytical testing including pH, viscosity, appearance, and stability * Analyze experimental and production data to identify trends, inconsistencies, and root causes * Conduct experiments with moderate independence to evaluate formulation variables * Support design transfer and scale-up activities from R&D to Manufacturing * Draft and update SOPs, batch records, work instructions, and formulation documents * Support equipment qualification, process verification, and validation activities * Collaborate cross-functionally with R&D, Quality, and Manufacturing * Provide guidance to junior chemists or technicians as needed *Minimum Qualifications (Required — Must Meet All)* * Bachelor’s degree in Chemistry, Biochemistry, Chemical Engineering, or related scientific field with 2–4 years of relevant experience OR Master’s degree in Chemistry/Biochemistry or related discipline with 1–3 years of relevant experience * Hands-on experience in formulation development, analytical testing, or regulated manufacturing (diagnostics, medical device, life sciences, or similar industry) * Proven hands-on experience in a GLP, GMP, or ISO 13485 regulated environment * Demonstrated experience formulating reagents, buffers, or solutions, including stability or performance testing * Experience supporting scale-up, design transfer, or process validation activities * Strong ability to analyze data, interpret experimental outcomes, and troubleshoot formulation challenges * Excellent documentation skills and adherence to data integrity and scientific recordkeeping standards * Ability to work in a laboratory environment and follow safety and contamination control procedures * Able to work on-site Monday–Friday in Carlsbad, CA *Preferred Qualifications* * Experience with immunoassays, ELISA, lateral flow, or IVD reagent development * Hands-on experience with protein conjugation (gold or latex particles) * Experience evaluating stability, compatibility, or performance studies * Familiarity with DOE, Lean, or Six Sigma methodologies * Experience supporting validation, scale-up, or design transfer *Why Join Lumos Diagnostics* * Mission-driven work improving diagnostic accuracy and accessibility * Hands-on laboratory environment with real impact on product performance * Collaborative team built on the values of: Take Ownership, Engage Openly, Act with Integrity, Move Together * Comprehensive benefits and competitive compensation * Opportunities for growth, development, and cross-functional collaboration *Application Requirements* To be considered, all screening questions must be answered in full. Incomplete applications will not be reviewed. Pay: $79,200.00 - $89,400.00 per year Benefits: * 401(k) matching * Dental insurance * Employee assistance program * Employee discount * Flexible schedule * Flexible spending account * Health insurance * Health savings account * Life insurance * Paid time off * Parental leave * Professional development assistance * Referral program * Vision insurance Application Question(s): * This position is full-time and on-site in Carlsbad, CA (Monday–Friday). Are you able to work on-site every day? * The compensation range for this role is $79,200–$89,400 annually. Are you comfortable with this range? * Do you have a Bachelor's degree in Chemistry, Biochemistry, Chemical Engineering, or a closely related scientific field? * Do you have 2–4 years of relevant, hands-on experience in formulation, analytical testing, or regulated manufacturing? * Have you worked in a regulated environment such as GLP, GMP, or ISO 13485? * Do you have hands-on laboratory experience preparing, testing, or optimizing formulations, buffers, or reagents? * Have you performed analytical testing such as pH, viscosity, appearance, or stability measurements? * Have you participated in scale-up, design transfer, process validation, or technology-transfer activities? * Have you worked with cross-functional teams such as R&D, Quality, or Manufacturing to troubleshoot or improve processes? * Are you comfortable spending the majority of your workday performing hands-on laboratory work (bench-scale and manufacturing-scale)? Education: * Bachelor's (Required) Work Location: In person
*Process Engineer III – Lumos Diagnostics* *Location:* Carlsbad, CA *Schedule:* Full-time, On-site *Compensation:* $109,000 – $130,000 annually *Join Lumos Diagnostics and Make an Immediate Impact* At Lumos Diagnostics, your engineering expertise directly supports our mission to deliver real-time, actionable diagnostic information that improves patient outcomes. Our Process Engineering team plays a critical role in optimizing the manufacturing processes that advance our diagnostic products. This is *not* an entry-level engineering role. We are seeking a Process Engineer with *proven, hands-on experience* in a regulated manufacturing environment who meets *all minimum qualifications* listed below. We are looking for an engineer who enjoys being actively involved in processes—*building, testing, validating, and improving them directly on the manufacturing floor*—while partnering cross-functionally to deliver scalable, high-quality solutions. *About the Role* In this role, you will design, develop, and optimize manufacturing processes that support efficient, reliable, and scalable production in an ISO 13485/cGMP environment. You will collaborate closely with Manufacturing, Quality, Supply Chain, R&D, and Product Development to evaluate current systems, identify improvement opportunities, and implement robust processes that enhance yield, throughput, and reliability. This position offers the opportunity to combine *technical design expertise* with *practical, on-the-floor execution*, driving meaningful improvements to operations and product performance. *What You’ll Do* * Design, develop, and implement new or improved manufacturing processes, tooling, and equipment to support scalability, yield, and efficiency. * Apply engineering and statistical methods (DOE, SPC, capability studies) to analyze process performance and drive continuous improvement. * Develop and execute validation protocols (IQ, OQ, PQ) and manage process changes within a regulated framework. * Work hands-on in the lab and on the production floor to prototype, test, validate, and troubleshoot equipment or process improvements. * Collaborate with Product Development and R&D to design and transfer new processes into manufacturing. * Author and maintain detailed process documentation, including SOPs, PFMEAs, work instructions, and flow diagrams. * Support and/or lead investigations and CAPAs, ensuring timely and compliant resolution. * Mentor technicians and operators on new processes, process controls, and best practices. *Required Qualifications (Candidates Must Meet All)* * Bachelor’s degree in Engineering (Mechanical, Biomedical, Chemical, Industrial, or a closely related field). * *4–7 years* of hands-on process engineering experience in a *regulated industry* (diagnostics, medical device, life sciences, pharmaceutical, or similar). * Direct experience in *process validation* including IQ, OQ, and PQ. * Experience with *change control*, process development, and manufacturing scale-up. * Demonstrated experience with *manufacturing automation*, equipment selection, or process implementation. * Proficiency using *DOE, SPC, and statistical problem-solving tools*. * Hands-on experience conducting *root-cause investigations and CAPAs*. * Experience authoring or maintaining regulated documentation (SOPs, PFMEAs, work instructions, process flow diagrams). * Ability to work on-site Monday–Friday in Carlsbad, CA. *Preferred Qualifications* * Experience with lateral flow assays or diagnostic product manufacturing. * Experience with FDA-regulated products. * Familiarity with advanced statistical process control tools. *Why Lumos Diagnostics* * Competitive salary: $109,000 – $130,000 annually * Comprehensive benefits including medical, dental, vision, life insurance, disability, and 401(k) with 4% company match * 3 weeks vacation, 9 sick days, 1 floating holiday, and 10 company holidays * Benefits begin the first of the month following hire * A collaborative, mission-driven team committed to quality, innovation, and continuous improvement *Our Core Values* * *Take Ownership:* Act with urgency and accountability. * *Engage Openly:* Listen, share ideas, and embrace feedback. * *Act with Integrity:* Do the right thing, even when it’s hard. * *Move Together:* Collaborate and win as one team. *Application Requirement* To be considered for this opportunity, *all screening questions must be completed in full*. Incomplete applications will not be reviewed. Pay: $109,000.00 - $130,000.00 per year Benefits: * 401(k) matching * Dental insurance * Employee assistance program * Employee discount * Flexible schedule * Flexible spending account * Health insurance * Health savings account * Life insurance * Paid time off * Parental leave * Professional development assistance * Referral program * Tuition reimbursement * Vision insurance Application Question(s): * This position is 100% on-site in Carlsbad, CA. Are you able to work on-site Monday–Friday, 7:30 a.m.–4:00 p.m.? * The compensation range for this role is $109,000–$130,000 annually. Are you comfortable with this range? * Do you hold a Bachelor's degree (or higher) in Engineering—Mechanical, Biomedical, Chemical, Industrial, or a closely related field? * Do you have 4–7 years of hands-on process engineering experience (NOT entry-level) in a regulated industry such as medical device, diagnostics, life sciences, or pharmaceutical? * Have you worked in an ISO 13485, cGMP, FDA-regulated, or similar quality system? * Do you have hands-on experience performing process validation, including IQ, OQ, and PQ? * Do you have experience with process development, equipment selection, or manufacturing scale-up? * Have you used statistical tools such as DOE, SPC, or process capability studies to solve engineering problems? * Have you led or participated in root-cause investigations or CAPA activities? * Have you authored or maintained regulated documentation such as SOPs, PFMEAs, work instructions, or process flow diagrams? * Are you comfortable working hands-on on the manufacturing floor and in the lab as part of your day-to-day responsibilities? Education: * Bachelor's (Required) Work Location: In person
*Manufacturing Technician I – Full-Time* *Location:* Carlsbad, California *Schedule:* Full-Time, Non-Exempt *Pay Range:* $20.05 – $22.36 per hour (depending on experience, internal equity, and market alignment) *Join a Team That Builds Diagnostics That Matter* At Lumos Diagnostics, every product you help assemble directly impacts patient care around the world. We are hiring *immediately* for motivated, team-oriented Manufacturing Technicians to support our growing production needs. If you enjoy hands-on work, thrive in a fast-paced environment, and want to be part of a mission-driven team, we encourage you to apply. *Schedule & Overtime Expectations* This is a *full-time, day-shift role*. The standard schedule is *Monday–Friday, 7:30 AM to 4:00 PM*. We are currently in a period of *high production demand through March 2026*. During these periods: * Work schedules *may be adjusted*, with at least two (2) weeks’ advance notice whenever possible. * This role *requires overtime*, which may include evenings and weekends. * As a *non-exempt employee*, you are eligible for overtime in accordance with California and federal law. * All overtime must be *pre-approved by your People Leader*. *What You’ll Do* * Assemble diagnostic cartridges, reagent kits, and related components following SOPs and specifications. * Operate manufacturing and assembly equipment in a clean, controlled environment. * Follow cGMP/GDP and ISO 13485 quality standards. * Maintain clean, safe, and organized work areas. * Accurately complete device manufacturing records and production documentation. * Collaborate with team members to meet daily production goals and support continuous improvement. *What We’re Looking For* *Minimum Qualifications* * High School Diploma or GED required * 0–1 year of experience in manufacturing, assembly, or related technical field * Ability to follow written and verbal instructions accurately * Strong attention to detail and commitment to producing high-quality work * Reliable attendance and punctuality * Ability to stand/walk for long periods and lift up to 50 lbs * Basic computer skills preferred *Preferred Qualifications* * Experience in a regulated environment (medical device, FDA, ISO 13485) * Familiarity with cleanroom operations and Good Manufacturing Practices (GMP) *Our Core Values* We are looking for candidates who embody our Lumos values: * *Take Ownership:* Act with urgency and accountability. * *Engage Openly:* Listen, share ideas, and embrace feedback. * *Act with Integrity:* Do the right thing, even when it’s hard. * *Move Together:* Collaborate and win as one team. *Why You’ll Love Working Here* * Competitive hourly pay * Benefits effective the first of the month following hire * Hands-on experience in a mission-driven diagnostic manufacturing environment * A collaborative team culture where your work directly supports healthcare. *Required Screening Questions* To be considered for this opportunity, *all screening questions must be fully completed*. *Incomplete applications will not be reviewed.* Pay: $20.05 - $22.36 per hour Expected hours: No less than 40 per week Benefits: * 401(k) 4% Match * 401(k) matching * Dental insurance * Employee assistance program * Employee discount * Flexible spending account * Health insurance * Health savings account * Life insurance * On-the-job training * Paid time off * Parental leave * Referral program * Tuition reimbursement * Vision insurance Application Question(s): * This position pays $20.05 – $22.36 per hour, depending on experience. Are you comfortable with this compensation range? * This is a full-time, day-shift role, Monday–Friday, 7:30 AM to 4:00 PM. Are you able to consistently work this schedule? * During periods of high production, schedules may be adjusted with at least two (2) weeks’ notice whenever possible. Are you able to work adjusted schedules if needed? * This role requires overtime, including weekends. Are you willing and able to work overtime as required? * Do you have 0–1 year of experience in manufacturing, assembly, or a related technical field? * Are you able to follow written and verbal instructions accurately? * Have you demonstrated reliable attendance and punctuality in previous roles? * Have you worked in a regulated manufacturing environment (such as medical device, ISO 13485, or FDA-regulated)? * Have you worked in a cleanroom environment or followed Good Manufacturing Practices (GMP/GDP)? * Are you able to accurately complete required documentation such as device manufacturing records, work orders, or SOP-driven forms? Education: * High school or equivalent (Preferred) Work Location: In person
Company Overview: Nikkiso Clean Energy & Industrial Gases is a leading provider of cryogenic pumps, heat exchangers, process systems, turboexpanders, services, and solutions for the liquefied natural gas (LNG), liquefied hydrogen (LH2), and industrial gases industries. Applications include fueling stations, marine engines, peak shaving, power generation, virtual pipelines, carbon capture, geothermal power and well stimulation. We are a subsidiary of Nikkiso Company Ltd, a leading industrial manufacturer headquartered in Tokyo, Japan, with $1.5 B USD in annual revenue, 8000 + employees worldwide, and publicly traded on the Tokyo Stock Exchange. Job Overview: Nikkiso Fueling & Solutions designs and constructs alternative fuel stations for fuels such as liquefied natural gas (LNG), compressed natural gas (CNG) and hydrogen (H2). Typical projects involve reinforced concrete mat foundations, installation of 45 ft. vertical or horizontal storage vessels, cryogenic and high pressure systems, ASME B31.3 pipe welding, process system installation, and hazardous area (CL 1 Div. 1 & 2 Group B or D) electrical work. We have an immediate need for an experienced Welder/Pipefitter to work on our requirements in the rapidly growing alternative fuel market. Our projects are typically design/build projects. We self-perform all engineering and specialty construction. Because we have a reputation of getting the job done, we are requested to do unique, one of a kind projects. Salary Range: $28 To $32 Per Hour Responsibilities: Stainless tube (1/4" – 3/4") installation Stainless and carbon steel threaded pipe (1/2" - 2") Stainless and carbon steel welded pipe per ASME B31.3 Pipe support and process skid installation GTAW and GMAW in 6G position Read blueprints and drawings and take or read measurements to plan layout and procedures Determine the appropriate welding equipment or method based on requirements Set up components for welding according to specifications (e.g. cut material with powered saws to match measurements) Operate angle grinders to prepare the parts that must be welded Align components using calipers, rulers etc. and clamp pieces Weld components using manual or semi-automatic welding equipment in various positions (vertical, horizontal or overhead) Repair machinery and other components by welding pieces and filling gaps Test and inspect welded surfaces and structure to discover flaws Maintain equipment in a condition that does not compromise safety Qualifications: Graduate of high school or GED Trade school and welding certificate preferred Satisfy pre-employment and random drug screening tests 5 + years of welding experience, preferably in stainless steel and carbon steel piping/pressure vessels Ability to pass NDT on weld performed in 6G position Complete understanding of blueprints and ability to work from written and verbal instruction Demonstrated ability to perform the job in a highly capable manner with minimum supervision Thorough experience using a wide variety of hand tools and capable of fitting and setting up details required for fabricated assemblies Knowledge of basic computer operation EEOC Statement: Equal Opportunity Employer/Veterans/Disabled Nikkiso CE&IG is proud to be an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Manufacturing Operator Job Description Revised July 2020 Supervisor’s Title: Manufacturing Supervisor Department: Manufacturing Location: Carlsbad, CA Exempt Status: Non-Exempt Position Backed Up By: Manufacturing Supervisor At Glanbia Nutritionals Inc., our portfolio centers on dairy and non-dairy nutritional ingredients. We co-innovate and deliver ingredient solutions and precision premixes for use in the mainstream food and beverage, infant and clinical, and functional nutrition markets. We are the number one provider of whey-based nutritional ingredients globally and the number one producer of American-style cheddar cheese. Our protein systems have transformed the bar and beverage categories — bringing increased levels of protein, cleaner labels and greater product functionality to market. We have a direct presence in 21 countries, with manufacturing facilities in the US, Germany and China, and international sales and technical offices around the world. Job Summary Responsible for the preparation, production and packaging of blend material. Provides assistance to the operator and fills in for basic operator duties as assigned. Maintain blend equipment and production area cleanliness. Must complete all applicable SOP and QA trainings. Essential Functions Box Room duties - tape boxes, insert foil/plastic liners, apply labels to boxes X2 Label bags 410 60 125, Zip tie liners, Tape filled boxes, Palletize boxes Hand clean separators, air flows, heat sealers, conveyors, scales, metal detectors 460 95 005, 460 95 023460 95 024, 460 95 004 and 510 95 000 Prepare cell for wash - cover electronics, remove scan gun, apply appropriate LOTO Able to identify status of equipment and cell 410 80 030 Operate hand jack Inspection of raw material and /or fill IBC (no set up) 350 60 060 Gather tools and supplies from tool room for blends or wash 410 60 004 Operate conveyor metal detector, includes HACCP metal checks 510 00 020 510 00 010 Scale Check 900 05 019 Scan in blends to NOAX Manufacturing and Inspection Cell Release 460 60 005 Seal foil and plastic liners Able to assist the operator with all blending, milling, packing tasks Identify ingredient name, lot number and item number Read and understand sequence of steps on BPR 410 80 037Screen, blend and package a variety of amino acids, vitamins and minerals, including those which are allergenic. Responsible for following the procedures for the preparation of blends and final blend product. Proper cleaning, blending, packaging and material inspection per Standard Operating Procedures. Proper cleaning of manufacturing equipment and production floor. Regular attendance is an essential function of this position. Following and living Glanbia values: Showing Respect, Winning Together, Finding a Better Way, Performance Matters, and Customers Champion. Each employee shall comply with occupational safety and health standards and all rules, regulations, and orders issued pursuant to the Occupational Safety and Health Act which are applicable to his/her own actions and conduct. Complies with all applicable food safety regulations and mandates (Safe Quality Foods, Food and Drug Admin, and State Ordinance) Additional Functions Perform other duties as assigned Qualifications High School Diploma or GED preferred. Completion of all training and development requirements of a Manufacturing Operator II Ability to work with amino acids, vitamins and fine chemicals in powder and liquid form as well as allergen products. Ability to follow direction and work with Standard Operating Procedures. Must be able to work flexible hours to include overtime and weekends on short notice Clear command of the English language both verbal and in writing. Basic computer knowledge. Typical Physical Activity Physical Demands The physical demands described represent those that must be met by an employee and the work environment characteristics are those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Regularly involves talking or listening, sitting, and the use of hands and fingers. Regularly involves going up and down stairs. Frequently involves reaching with hands and arms, standing and walking. Occasionally involves crouching, stooping, kneeling and/or climbing or balancing. Physical Requirements Must be able to lift and carry items weighing up to 55 pounds. Manual dexterity sufficient to reach/handle items, works with the fingers, and perceives attributes of objects and materials. Involves moderate physical activity performing non-strenuous daily activities of a primarily administrative nature. Should be able to identify and distinguish colors, see clearly at 20 inches or closer and 20 feet or more, observe an area that can be seen up and down or to the left and right while eyes are fixed on a given point, judge distances and spatial relationships, and adjust the eye to bring an object into sharp focus. Typical Environmental Conditions May be exposed to moderate noise levels (i.e. office equipment, light traffic). May be exposed to moderate to high noise levels (i.e. production equipment, forklifts, heavy traffic). May be exposed to humidity, intense heat and cold, outdoor weather conditions, and fumes and toxic chemicals. May work in areas with mechanical moving parts, above ground with risk of fall, or areas with risk of electrical shock. Travel Requirements N/A Disclaimer Must perform the essential duties and responsibilities with or without reasonable accommodation efficiently and accurately without causing significant safety threat to self or others. The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and/or skills required of all personnel so classified. At Glanbia, we celebrate diversity, because we know that our individual strengths make us stronger together. We welcome and encourage interest from a wide variety of candidates, and we will give your application consideration, without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, or disability status. At Glanbia our culture will celebrate individuality, knowing that together we are more.
Job Information Number ICIMS-2025-9580 Job function QA&RA Job type Temporary Location San Diego - WBH - 6260 Sequence Drive San Diego, California 92121 United States Country United States Shift 1st About the Position Introduction Werfen Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong. Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We’re passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care. Overview The Quality Systems (QS) Specialist I is responsible for assisting in the planning, coordination, control, and continuous improvement of key components of the Quality Management System (QMS), which helps to ensure compliance to GMP requirements, FDA & ISO standards, and other regulations as they pertain to the QMS. The pay range for this position is currently $33.65-$40.87 hourly. Individual compensation is based on the candidate’s qualifications for the position, including experience, skills, knowledge, education, certifications, internal equity, budget, and/or other business and organizational needs. This is a full-time, temporary position through June 2026. Responsibilities Key Accountabilities The QS Specialist I will be expected to support some of the activities within the Quality Systems team shown below but will have primary responsibility for at least one of the following: CAPA process – tracking, trending of approved CAPAs, and driving timely/appropriate completion of activities. Deviation process – tracking, trending, and driving timely/appropriate closure. Internal Audit program –transfer of any nonconformities issued to the CAPA process and driving timely/appropriate closure. Quality Plans – issuing number, tracking status, appropriate closure. Quality Records – scan, inventory, archive and retrieve quality records; maintain off-site master inventory list. Design Control – support the DHF/DCR creation, maintenance, and archival process; conduct DHF/DCR reviews/audits; act as an independent reviewer during design review. Quality Systems Activities: CAPA. Deviation process. External Document process. Quality Agreements. International QMS compliance with Werfen Affiliates. Quality Plans. Training program. Helps facilitate meetings related to QS activities by taking minutes as directed. Supports change orders/process improvements with respect to Quality Management System procedures with direction from management. Provides support to quality assurance activities for regulatory compliance, (i.e., Management Review support, Regulatory audits). Assist with development and maintenance of a variety of metrics pertaining to Quality System activities as assigned, including data for Management Review and KPIs Participates in internal, external and/or 3rd party audits, as needed. Provides support through a general working knowledge of all Werfen Quality System programs. Aids employees based on a clear understanding and implementation of regulatory standards. Carries out duties in compliance with established business policies. Interface with all functions and levels of management as needed. Maintain the accuracy, legibility, traceability and retrieval of quality documents and records. Other duties as assigned, according to the changing needs of the business. Qualifications Minimum Knowledge & Experience required for the position: Bachelor’s degree (Life Sciences) preferred. Minimum of two (2) years relevant experience or one (1) year related experience with an advanced degree required. Previous Quality Assurance experience within a GMP-regulated environment required. Skills & Capabilities: Good understanding of record retention. Strong planning, organizational and time management skills are required. Ability to prioritize urgent matters. Basic understanding of US FDA Quality System Regulations (QSR) is required. Basic understanding of ISO 13485:2016 is required. Good understanding of Good Manufacturing Practices & Good Documentation Practices. Basic understanding of change control requirements. Computer literacy required; good working knowledge of Microsoft Office programs, especially Power-point required. Experience with Enterprise Resource Planning (ERP) system (such as SAP) preferred. Technical writing background/experience is a plus. If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV. Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact NAtalentacquisition@werfen.com for assistance. We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team. www.werfen.com
Job Information Number ICIMS-2025-9602 Job function QA&RA Job type Full-time Location San Diego - AID - 9900 Old Grove Road San Diego, California 92131-1638 United States Country United States Shift 1st About the Position Introduction Werfen Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong. Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We’re passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care. Overview Job Summary Autoimmunity Sr. Managers are responsible for managing the overall operations, business results and performance for their assigned department(s). Responsible for department functional plans, determining current and future position profiles and staffing needs, proposing and managing department budgets, performance metrics and reporting, analyzing operations to identify gaps, ensure compliance, safety, and ongoing process improvements, as well as leading and developing lower-level management staff and high performing teams. The Sr. Manager, Quality System leads by setting a clear vision, fostering collaboration across teams, and driving continuous improvement in quality management. This role empowers staff through coaching and feedback, ensures accountability for results, and models company values and compliance. The Sr. Manager proactively maintains collaborative relationships across the organization to meet goals and produce complaint products and services. The position oversees organizational activities to ensure the effectiveness of the Quality Management System. All activities are performed in accordance with standard operating procedures, Quality Management System, safety, and administrative regulations. Responsibilities Key Accountabilities Department Management Implement strategies to achieve company objectives. Ensure staff understand objectives and expectations related to them. Manage department headcount budget to ensure effective resource planning, including recruitment, interviewing, selection, training, coaching, development, coordination of assignments and workload priorities, goal setting, termination, and performance management. Ensure effective use of company’s performance management program, including setting expectations, providing timely and meaningful feedback, ensuring understanding, holding staff accountable, while supporting employees’ development goals. Educate and broaden the Quality knowledge within the teams; develop and deploy personnel skill assessment and training plans. Ensure regular and meaningful communication throughout team, and with department management, through effective use of one-on-one meetings, team meetings and other forms of formal and informal communication. Manage and lead lower-level management staff to ensure high performing teams and department operations. Includes accountability to Werfen’s People Manager Competencies and Expectations. Monitors department personnel and operations to pre-empt employee issues. Proactively manages employee relations issues; uses judgement in consulting with department senior leadership and Human Resources. Assesses the need for new or improved operations. Delegates responsibility or may directly author, implement, and ensure maintenance of departmental procedures, work instructions, and templates associated with the quality System activities. Develops metrics and data collection methodologies, interprets data to make recommendations to Department Senior Leadership and prepare reports on the performance of the quality system, including management-requested reports and management review meetings minutes. Proposes department budget and monitors department expenditures. Continuous Improvement Work closely with management by contributing to and proactively driving strategies and plans to achieve Quality Objectives. Ensure Quality Management System effectiveness by driving continuous improvement, implementing controls and mitigating risks using audits and data analysis; coordinating actions to improve processes and metrics; and proactively managing critical quality issues. Foster productive relationships and collaboration within Autoimmunity, Werfen manufacturers, and Affiliates. Lead and manage department and cross-function projects as well as operational tasks Quality System Activities Ensure Quality Management System efficiency using data-driven tools across corrective and preventive actions, internal & external audits management, document & records management, compliance administration, stop shipment management, change management, quality system training, management review, supplier management, quality improvements, quality monitoring and reporting, and nonconformance/deviations management. Facilitate a quality culture and promote collaboration, quality requirements understanding and continuous improvement by actively engaging with other organizational functions. Acquire and maintain current knowledge of regulatory compliance and industry practices through reviews of publications, conferences, and publicly available information to properly adjust compliance activities and approaches. Document Control Develop and maintain document control policies and procedures tailored to IVD regulatory requirements. Manage the creation, review, approval, revision control, change traceability, distribution, and archival, and retrieval of controlled documents and quality records. Administer and optimize Electronic Document Management Systems (EDMS). Educates and supervises staff to ensure compliance with applicable Inova SOPs, ISO, FDA and other Quality System Regulations, as well as applicable Environmental, Health & Safety, Human Resources and all other regulatory and administrative policies. Represents the AID management team and reflects Werfen Values as a role model to employees, suppliers, and customers. Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions. Networking/Key relationships Manufacturing teams Regulatory teams R&D teams including Manufacturing Technical Suppor Contract manufacturers Quality Control Product Complaint Group Suppliers Senior and Executive Management Affiliates Other Werfen Affiliate and Manufacturer’s functions Qualifications Minimum Knowledge & Experience required for the position: Education: Bachelor’s degree in biology, biochemistry, life science, engineering, or equivalent required. Advanced degree preferred. Certified Medical Device Auditor (preferred). Experience: A minimum of 10 years of progressive quality experience in in-vitro diagnostics. At least 8 years of experience managing or leading junior level management and teams required, preferably in a regulated manufacturing environment. At least 3 years of successful auditing and inspection experience including managing the preparation for and hosting of Regulatory Inspection including successfully resolving issued nonconformance/violations e.g., 483s. Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement. Skills & Capabilities: Advanced expert knowledge of current regulatory Quality Management Systems requirements including US Quality System Regulations (QSMRs), EU in Vitro Diagnostics Regulations (IVDR), ISO 13485, ISO 14971, and other regulations and standards. Apply this knowledge to ensure organizational compliance. Ability to integrate advanced quality principles, document and record configuration and management, Lean Principles, and risk management into daily operations to optimize scalable processes which will balance compliance with business goals. Ability to utilize critical thinking and sound systemic decision-making skills to analyze complex situations, evaluate alternatives and implement optimal solutions. Demonstrates advanced interpersonal and emotional intelligence skills, building trust and report to develop and lead highly functioning teams and collaborate across organizational boundaries. Ability to function effectively in ambiguous and rapidly changing environment, demonstrating flexibility, adaptability and resilience. Influences and negotiate with stakeholders to achieve mutually beneficial outcomes, maintain strong, positive working relationships. Proactively prevent and resolve conflicts, while fostering a constructive and inclusive work environment. Independently identifies, assesses, and mitigates risks, applying systematic problem-solving methodologies and root cause analysis to prioritize and resolve quality issues. Demonstrates advanced verbal and written communication skills, including the ability to prepare and deliver effective presentations and training materials, communicating complex concepts clearly to diverse audiences. Possesses advanced skills in Microsoft Office Suite (Word, Excel, Access, Outlook, PowerPoint, Visio, Adobe Acrobat), leveraging these tools for data analysis, reporting, and documentation. Applies data-driven analytical skills to interpret information, support decision-making, and drive continuous improvement initiatives. Applies a thorough understanding of standard finance and budgeting processes, including profit and loss, balance sheet, and budget management, to support departmental planning and resource allocation. Knowledge of employment laws and experience in monitoring compliance and addressing employee relations matters. Travel requirements:No routine travel requirements. Location / Office Must reside in the San Diego area Must be present in the office Mon – Friday Supervisory Experience Prior experience managing direct reports is required Work Environment: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is regularly required to communicate. Must be able to detect, identify and inspect scientific data. The employee will be required to stand and/or walk up to 8 hours per day and/or sit for up to 8 hours per day. Must be able to use hands to feel objects, including keyboard, telephone and pipettes or other lab equipment. May need to reach with hands and arms, climb stairs, balance, stoop, kneel or crouch. Will be required to talk and hear and have specific vision abilities, including close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus. May occasionally have to lift and/or move up to 25 pounds. The noise level in the work environment will vary but is usually moderate. Other Duties and Acknowledgement: The above statements are intended to describe the general nature and level of work being performed by the incumbent. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of this position. Note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. This job description does not constitute or contain a contract or employment promise of any kind. Nothing contained herein modifies the at-will nature of employment with Werfen. The salary range for this position is currently $135,000- $195,000 annual. Individual compensation is based on the candidate’s qualifications for the position, including experience, skills, knowledge, education, certifications, internal equity, budget and/or other business and organizational needs. If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV. Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact NAtalentacquisition@werfen.com for assistance. We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team. www.werfen.com If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV. Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact NAtalentacquisition@werfen.com for assistance. We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team. www.werfen.com
Job Information Number ICIMS-2025-9614 Job function Manufacturing Job type Full-time Location San Diego - AID - 9900 Old Grove Road San Diego, California 92131-1638 United States Country United States Shift 1st About the Position Introduction Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong. Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We’re passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care. Overview Job Summary Werfen Autoimmunity Manufacturing Associates play a critical role in the manufacturing and/or testing of a variety of Autoimmune-related diagnostics products. This position is responsible for the manufacture and/or testing of components of diagnostic kits used by clinicians around the world for the diagnosis of autoimmune disorders. Our Manufacturing Associates work in a highly specialized team environment, using advanced automated equipment and instrumentation to manufacture and test in-process components and raw materials. Employees help ensure product quality by participating in troubleshooting and developing quality improvements within our multiple value streams. Work is performed under department supervision and in accordance with the company’s Quality Management System. Employees working in the ELISA team manufacture ELISA plates, calibrators and controls, and all other related components. Employees working in the IFA team manufacture IFA slides, controls, bulks and all other related components. Employees working in the QUANTA Flash and Aptiva team manufacture coupled beads, calibrators, controls, and all other related components. Employees working in the Product Testing team test products from all product lines (ELISA, IFA, QUANTA Flash, and Aptiva) and all other related components. Employees working in the Biotechnologies Manufacturing team manufacture raw materials for use in the manufacturing processes for all product lines (ELISA, IFA, QUANTA Flash, and Aptiva). Responsibilities Key Accountabilities Under supervision follows standard operating procedures, work instructions, and other pro-cedures for routine manufacturing and/or testing. Participates in the bulking and/or evaluation of in-process components and reagents ac-cording to procedures. Packages, fills, and operates equipment to ensure in-process components are completed (if applicable). Maintains detailed Device History Records and/or any other associated documentation for all manufacturing activities. Operates and cleans equipment and instrumentation for routine manufacturing and/or test-ing. Assists with evaluations of raw materials (if applicable). Follows established safety and environmental procedures. Maintains lab and work area in a clean and orderly manner. Complies with applicable Werfen standard operating procedures (SOPs), ISO, FDA and other Quality System regulations, as well as applicable Environmental Health & Safety (EHS), Human Resources and other regulatory and company policies. Reflects Werfen Values in the quality of work and in working relationships. Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions. Qualifications Minimum Knowledge and Experience: Education: Bachelor’s degree in biologicial or related sciences required. Certificate program or A.S. degree with 3-4 years relevant experience in a life sciences laboratory may be substitued for a degree. Experience: 0-1 years of life sciences laboratory experience required. Experience in a regulated manufacturing environment in the healthcare sector strongly preferred. Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement. Skills & Capabilities Basic understanding of basic laboratory practices and procedures. Basic understanding of Good Manufacturing Practices. Strong attention to detail and commitment to quality. Attentiveness to details to spot flaws in products or problems with equipment to prevent quality issues. Problem-solving ability to troubleshoot and resolve issues. Time management skills to meet production goals without compromising quality. Ability to work collaboratively in a team environment. Curiosity and commitment to continuous learning. Work EnvironmentThe physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is regularly required to communicate. Must be able to detect, identify and inspect scientific data. The employee will be required to stand and/or walk up to 8 hours per day and/or sit for up to 8 hours per day. Must be able to use hands to feel objects, including keyboard, telephone and pipettes or other lab equipment. May need to reach with hands and arms, climb stairs, balance, stoop, kneel or crouch. Will be required to talk and hear and have specific vision abilities, including close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus. May occasionally have to lift and/or move up to 25 pounds. The noise level in the work environment will vary but is usually moderate. This position is very active and requires varying levels of mobility. The annual base salary range for this role is currently $25/hr to $30/hr. Individual employee compensation will ultimately depend on factors including education, relevant experience, skillset, knowledge, and particular business needs. This role is eligible for medical, dental, and vision insurance, 401k plan retirement benefits with an employer match, as well as paid vacation and sick leave. Our sales roles are eligible for participation in a commission plan and our management, and select professional roles, are eligible for a performance-based bonus. If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV. Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact NAtalentacquisition@werfen.com for assistance. We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team. www.werfen.com
Description: About Quantum Design For more than 40 years Quantum Design (QD) has been providing technology solutions to researchers in the fields of physics, chemistry, biotechnology, materials science, and nanotechnology. Established in 1982, Quantum Design is the leading commercial source for automated materials characterization systems offering a variety of measurement capabilities. QD instruments are found in the world's leading research institutions and have become the reference standard for a variety of magnetic and physical property measurements. The Opportunity As a Final Test Technician, you’ll perform the final testing and calibration of advanced scientific instruments before shipment. You’ll set up and operate QD systems, verify their performance, and collaborate with engineers to ensure each product meets our rigorous quality standards. Responsibilities Verify magnet operation, temperature control, and system stability within design specifications. Provide feedback on manufacturability and serviceability of systems based on test observations. Assist in developing automated test scripts or updating test procedures. Uses standardized tools and electronic equipment (i.e., hand tools, computers, multimeters, leak checkers) to assemble/install/remove or perform testing and troubleshooting. Interfaces with engineers to support special tests and experiments with detailed instructions. Operates specialized laboratory equipment. Sets up moderately complex tests and calibrates equipment prior to shipment. Identifies operation or equipment problems and reports defects. Collects and summarizes test data and collaborates with engineers to understand deficiencies. Inventories and stage parts for product shipments. Follow written test procedures and instructions. Performs other duties as assigned. Requirements: Minimum Qualifications One year of experience in a testing environment, laboratory setting, or experimental operations High School diploma or equivalent Familiarity with using standard tools and electronic equipment such as hand tools, digital multimeters, leak checkers, torque drivers, wrenches, and computers for assembly, testing, and troubleshooting Computer skills including proficiency with Excel Preferred Qualifications Associate's degree in a technical field Experience with LabVIEW Experience reading engineering drawings Excellent teamwork and interpersonal communication skills. Aptitude for analytical, problem-solving, and critical-thinking skills. Ability to work under pressure when meeting tight deadlines Additional Information 5 days a week on-site position. The selected candidate will be required to work at our San Diego, CA location. Physical Demands and Work Environment: The employee may occasionally lift and/or move up to thirty-five pounds. Ability to work in various settings with moderate to loud noise levels While performing the duties of this job, the employee must sit; walk; talk; hear; use hands to keyboard, finger, handle, and feel; stoop, kneel, crouch, twist, reach, and stretch. Ability to work safely on systems that have unusual conditions such as high pressures, high voltage, high energy, and cryogens Quantum Design is an affirmative action and equal opportunity employer. All employment decisions, policies and practices are in accordance with applicable federal, state and local anti-discrimination laws. Quantum Design will not tolerate or engage in unlawful discrimination including any form of unlawful harassment, on account of a person's sex, age, race, color, religion, creed, sexual preference or orientation, marital status, national origin, ancestry, citizenship, military status, veteran status, handicap, disability, or membership in any protected group.