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JOB DESCRIPTION Department: Quality Assurance Job Title: Quality Engineer Reports To: Quality Leadership Location: Vista, CA (onsite position) Status: Full-Time SUMMARY VQ OrthoCare provides noninvasive medical products focused on orthopedic bracing and electrotherapy. The Quality Engineer is responsible for applying quality engineering principles and analytical methods to support product and process quality through investigation, analysis, auditing, controlled change and cross-functional quality activities. The position evaluates product and process issues, supports corrective action and continual improvement and develops subject-matter expertise in assigned areas of the Quality Management System. ESSENTIAL DUTIES AND RESPONSIBILITIES The Quality Engineer independently performs assigned Quality activities and works collaboratively with Quality, Manufacturing, Product Development and other functional areas to support effective Quality System and product quality outcomes. Apply Quality System principles and requirements in accordance with Company procedures, ISO 13485 and applicable FDA medical device requirements. Serve as an internal QMS auditor, independently planning and performing assigned audits of Quality System processes and applicable business functions against ISO 13485, Company procedures and other applicable requirements; evaluate objective evidence, document findings and support appropriate follow-up. Develop and maintain extensive knowledge of Company products, components, specifications, manufacturing processes, inspection requirements and known failure modes to support effective Quality evaluation and decision-making. Investigate product defects and failures, including evaluation of returned product and relevant product, manufacturing, complaint and Quality history, to characterize failure modes, determine contributing factors and identify recurring or potentially systemic conditions. Collect, analyze and interpret product and Quality data to identify trends, variation, recurring conditions and potential quality signals and contribute to the development of meaningful data collection, analysis and reporting methods. Lead assigned corrective action, nonconformance, root-cause investigation and Quality improvement activities or participate as an active member of cross-functional teams responsible for evaluating and resolving Quality issues. Prepare and update controlled documents as assigned, including initiating change documentation, developing required revisions, obtaining appropriate technical and functional input, verifying proposed changes, evaluating impacts and related downstream activities and completing applicable requirements through the Company's self-service documentation process. Support maintenance of Device Master Record (DMR), technical file and other applicable product documentation by completing assigned updates, verifying current and applicable documentation and supporting alignment of affected records and repositories following approved changes. Work cross-functionally with Manufacturing, Inspection, Product Development and other applicable functions to address product and process quality issues and support implementation of appropriate corrective and improvement actions. Support development and revision of inspection plans, acceptance criteria, sampling methods and other product quality controls associated with product, process, specification and controlled-document changes. Provide backup support for Quality Inspection and other Quality workflows as needed, performing assigned activities in accordance with established procedures, specifications and acceptance requirements. Develop subject-matter expertise and assume responsibility for assigned Quality System areas as knowledge, proficiency and organizational needs evolve. QUALIFICATIONS Five to seven years of progressive Quality experience in a medical device or other regulated manufacturing environment. Working knowledge of ISO 13485, FDA medical device Quality System requirements, and Quality assurance and Quality engineering principles. Demonstrated experience with product and process investigations, root-cause analysis, corrective action and Quality improvement. Demonstrated experience independently performing internal QMS audits and evaluating objective evidence against established requirements. Experience analyzing Quality and manufacturing data and applying specifications, inspection requirements, acceptance criteria, sampling methods and other product quality controls. Experience with controlled change in a regulated Quality Management System and working cross-functionally with Manufacturing, Inspection, Engineering, Product Development and other operational functions. Preferred: Experience with Class I and Class II medical devices. CERTIFICATIONS ISO 13485 Internal Auditor or Lead Auditor training/certification preferred. Evidence of completed auditor training should be provided. ASQ certification or demonstrated professional development in Quality auditing, Quality engineering, Quality improvement or related Quality disciplines is preferred. COMPETENCIES Ability to interpret and apply Quality System procedures, standards, specifications and applicable requirements. Strong analytical and investigative skills with the ability to evaluate evidence, identify patterns, determine broader Quality implications, and reach supportable conclusions. Working knowledge of root-cause analysis, corrective action, risk-based thinking and continual improvement principles. Ability to understand established processes and current-state requirements before recommending or implementing change. Ability to independently plan and execute assigned work, exercise sound professional judgment, and recognize when additional expertise or escalation is required. Strong cross-functional communication, collaboration, organization, documentation and follow-through. SUPERVISORY RESPONSIBILITIES This position does not have supervisory responsibilities. PHYSICAL AND MENTAL DEMANDS Regularly required to sit, stand, walk, type, read, review records and use computer systems. Ability to work within office, manufacturing, warehouse and inspection environments. Ability to examine products and components and review specifications, processes, records, data and other technical information. Ability to manage multiple priorities, conduct investigations and exercise professional judgment within a regulated environment. WORK ENVIRONMENT Reasonable accommodations may be provided to allow qualified individuals with disabilities to perform the essential duties and responsibilities. The work environment may include office, manufacturing, warehouse, inspection, supplier, customer and audit settings consistent with assigned Quality responsibilities.
Quality Compliance & Document Control Specialist Location: Escondido, CA - Onsite Reports To: Quality Manager Pay Range: $75-95,000 Position Summary ARCH Medical Solutions is seeking a detail-oriented and proactive Quality Compliance & Document Control Specialist to support the maintenance, effectiveness, and compliance of our Quality Management System (QMS). This role combines responsibility for document control, training administration, audit readiness, regulatory compliance, quality records management, and continuous improvement initiatives within a precision machining environment serving the medical device industry. The ideal candidate will have experience with ISO 13485, document control processes, quality systems administration, internal audits, and regulatory compliance. This individual will work closely with cross-functional teams to ensure quality documentation remains accurate, current, and compliant with customer and regulatory requirements. Essential Duties and Responsibilities Quality Management System (QMS) Maintain and continuously improve the Quality Management System in accordance with ISO 13485, FDA regulations, customer requirements, and company standards. Manage QMS documentation, procedures, forms, policies, and records to ensure current revision status and availability. Support external customer audits, surveillance audits, recertification audits, and regulatory inspections. Coordinate and support the Internal Audit Program. Assist with CAPA, customer complaint investigations, NCMRs, and corrective action activities. Perform quality data analysis and trend reporting related to customer complaints, scrap, quality metrics, and process performance. Support development and implementation of continuous improvement initiatives. Conduct QMS-related training and maintain training compliance records. Serve as a resource regarding quality policies, procedures, and regulatory requirements. Document Control & Records Management Maintain control of all quality system documentation and related records. Ensure procedures, work instructions, SOPs, forms, and engineering documents are properly reviewed, approved, distributed, and archived. Manage document revision history and associated document control logs. Process Engineering Change Orders (ECOs) and track implementation activities. Create and update inspection forms, method sheets, and balloon/bubble drawings. Maintain Device History Records (DHRs) and quality records in accordance with customer and regulatory requirements. Manage approved supplier documentation and supplier quality agreements. Facilitate employee training on new or revised procedures and ensure training records are maintained. Provide administrative support including scanning, filing, labeling, printing, and record retention activities. Compliance & Cross-Functional Support Assist with contract and customer requirement reviews to ensure compliance. Monitor and maintain quality-related KPI data and reporting. Collaborate with HR and department leaders to maintain training matrices and onboarding documentation. Support ERP system data entry and maintenance related to quality and documentation activities. Interface with customers and suppliers regarding quality documentation and compliance matters. Participate in root cause investigations and quality improvement projects. Perform other duties as assigned. Qualifications Education & Experience Associate degree in a technical, quality, engineering, or related field with 3+ years of relevant experience; or Bachelor's degree in Quality, Engineering, Life Sciences, or related discipline preferred; or Equivalent combination of education and experience. Experience in Quality Systems, Document Control, or Regulatory Compliance within a regulated manufacturing environment. Experience supporting ISO 13485 quality systems Experience with medical device manufacturing preferred. Experience with ERP systems, document management systems, and electronic quality records preferred. Knowledge, Skills & Abilities Working knowledge of ISO 13485 and FDA Quality System Regulations. Strong understanding of document control processes and best practices. Experience conducting internal audits and supporting external audits. Knowledge of CAPA, complaint handling, root cause analysis, and continuous improvement methodologies. Proficiency in Microsoft Word, Excel, Outlook, and document management systems. Excellent written communication and technical editing skills. Strong organizational skills with exceptional attention to detail. Ability to manage multiple priorities and meet deadlines. Ability to work independently and collaboratively in a fast-paced manufacturing environment. Preferred Certifications ASQ Certified Quality Auditor (CQA) ISO 13485 Internal Auditor Certification Why Join ARCH Medical Solutions? Play a critical role in maintaining compliance and quality excellence. Contribute directly to products used in life-changing medical devices. Work with a collaborative team focused on continuous improvement and operational excellence. Opportunities for professional growth within a growing medical manufacturing organization. Additional Notes ARCH Global Precision is an Equal Opportunity Employee and wholeheartedly supports diversity in the workplace as a basic premise for business success. All employees of ARCH Global Precision are employed on an at-will basis. This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employee(s) will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorized to give instructions or assignments. A review of this position has excluded the marginal functions of the position that are incidental to the performance of fundamental job duties. All duties and responsibilities are essential job functions and requirements and are subject to possible modification to reasonably accommodate individuals with disabilities. To perform this job successfully, the incumbent(s) will possess the skills, aptitudes, and abilities to perform each duty proficiently. Some requirements may exclude individuals who pose a direct threat or significant risk to the health or safety of themselves or others. The requirements listed in this document are the minimum levels of knowledge, skills, or abilities. Equal Opportunity Employer This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights (https://www.eeoc.gov/poster) notice from the Department of Labor.
Quality Administrator/Document Control At AeroFlow Technologies, we specialize in creating complex tube and duct assemblies using high-performance materials capable of withstanding extreme pressure, temperature, and chemical interactions. You can even find our products aboard NASA’s Space Launch System and in the F-35 fighter jets. That’s the level of quality and innovation you’ll be part of when you join our team. We are looking for a Quality Administrator/Document Control to join our team which will help support our Aerospace business. ESSENTIAL FUNCTIONS: Implement and maintain system that are related to the AS &ISO Quality Management System. Maintain the electronic and hard-copy document control system in accordance with AS9100 and internal procedures. Conduct internal quality system audits and maintain audit schedule. Document, file and identify raw material and associated certifications. Monitor and track quality objectives, metrics, and departmental KPIs. Support continuous improvement initiatives and quality system effectiveness. Track due dates and follow-up activities for corrective and preventive actions. Assist with root cause investigations and preparation of customer responses. Prepare Certification packages for outgoing product. Schedule and coordinate outbound shipments with approved carriers, freight providers, and customer-designated transportation services. Scan, organize, and electronically archive completed job folders in accordance with customer, regulatory, and company record retention requirements. Maintain electronic and hard-copy filing systems to ensure traceability, accessibility, and preservation of quality records. Retrieve archived job documentation and quality records as needed to support customer inquiries, audits, corrective actions, and internal investigations. Support front-office administrative functions as needed. Answer incoming telephone calls in a professional and courteous manner and direct calls to the appropriate department or personnel. QUALIFICATIONS REQUIRED: · Familiarity with gages and measurement techniques. · Able to understand and interpret blueprints, specifications, operations sheets, etc. · Understands Geometric Dimensioning and Tolerancing. · Self-starter who is comfortable with hands-on activities. EXPERIENCE/EDUCATION REQUIRED: · 2 years of Quality experience in a manufacturing environment · High School graduate · Computer literate (Microsoft Word, Excel and PowerPoint) Salary range: $24.00 to $30.00 an hour based on experience Hours: Monday thru Friday 6:30 am to 3:00 pm Full Benefits: Medical, Dental, Vision, Life and Paid Time Off Reasons You’ll Love It Here We offer a full suite of employee benefits such as medical, dental, and vision insurance; as well as paid vacation, paid personal time, and various opportunities to give back to your local community. We also strongly encourage and provide opportunities for learning and professional development. Our Learning & Development team has put together in-house training on subjects like front-line supervisor essentials, how to manage conflict in the workplace, and many others. What to Do Next Now that you’ve had a chance to learn more about us, what are you waiting for! Apply today and allow us the opportunity to learn more about you and the value you can bring to our team. Once you apply, be sure to create and sign up for job alerts, so you can be the first to know when new opportunities become available. Our Commitment to You We’re proud of the fact that we are strongly rooted in being an inclusive, people-focused organization. Our company culture reflects values like integrity, ownership, and authenticity. We take these to heart, and if you do as well, you’ll fit right in. AeroFlow Technologies is committed to the full inclusion of all qualified individuals. In keeping with our commitment, we will take the steps to assure that people with disabilities are provided reasonable accommodations. Equal Employment Opportunity/Affirmative Action/Veteran/Disability Employer For specific regional privacy notices please refer to our Privacy Policy.
Malin Space Science Systems (MSSS) is a private technology company that designs, develops and operates space camera systems for government and commercial aerospace customers and provides services in spacecraft instrument operations and space science research. As a member of our multidisciplinary space imaging systems design team, the Flight Assembly Technician is responsible for high-level assembly of prototype and spaceflight electronics under the direction of Production Supervisor or Production Management. *Essential Functions* * Assembles electronic, mechanical, optical, and cable harness assemblies by following detailed work instructions and applicable NASA and IPC workmanship standards. * Maintains detailed assembly records. * Assists hardware engineering in assembly of prototype electronics and cable harnesses, testing, troubleshooting, and mechanical integration. * Maintains all required NASA trainings and recertifications. * Performs ESD check-in on a daily basis. * Cross-trains in assembly disciplines to support all aspects of work completion. * Participates in team meetings and provides updates on work status. * Maintains work area, tools and equipment. Performs required maintenance as needed. * Prior to entering assembly, test, storage or development areas within the Camera Systems Group unescorted, receive initial and ongoing annual training in the fundamentals of Electrostatic Discharge (ESD). *Non-Essential Functions* * Travels to customers and/or vendors as required. * Performs other duties as required or requested which may become essential to this position. *Minimum Qualifications* * High-School Graduate / GED required. Some college or Trade School / ROP certification desired. * Minimum of 3 to 5 years’ experience. * Excellent hand soldering, cable harness assembly, mechanical assembly, documentation, organization, and communication skills. * Excellent attention to detail and ability to work closely with each member of a production team. * Must be able to read schematics and mechanical drawings and precisely follow detailed written instructions. * J-STD-001 certification is required. Space Addendum certification is preferred and is a requirement to perform the position. * Polymerics mix and application experienced preferred; will be required to obtain NASA-STD 8739.1 certification. * Must be computer literate with knowledge of MS Excel and Word. * Results-oriented, self-motivated and dependable. * Hands-on machinist experience for manufacturing test fixtures is preferred. * Ability to work outside of regular business hours. * Occasional travel to customers and/or vendors may be required. *Comp: * $28-31/hr *Physical Requirements* Must be able to remain in a stationary position operating lab equipment for periods of time. Must be able to perform repetitive soldering tasks under a microscope to properly position hardware. Ability to inspect parts and assemblies under a microscope to determine product placement. Ability to work and move around in a cleanroom environment, wearing required outer garments including smock/coveralls, shoe covers, mask, goggles, hood, gloves and ESD wrist strap. Must be able to communicate clearly with a variety of people on a daily basis. Must be able to traverse spaces in and around the office, labs, and machine shop as applicable. Ability to lift and carry up to 10 lbs. as needed. Possess mental acuity at a level which will facilitate execution of complex technical instructions. Ability to practice safe driving habits while following all state safety regulations and standards. Ability to handle high stress levels in connection with multiple conflicting priorities and deadlines. High tolerance for ambiguity and shifting expectations. Ability to travel to customers and/or vendors locations. *Disclaimer* The employee must be able to perform the essential functions of the position satisfactorily and, if requested, reasonable accommodations will be made to enable employees with disabilities to perform the essential functions of their job, absent undue hardship. The Employer retains the right to change or assign other duties to this position. _MSSS is committed to providing equal employment opportunities to all individuals, regardless of any protected status, including veterans and individuals with disabilities._ Pay: $28.00 - $31.00 per hour Benefits: * 401(k) * Dental insurance * Flexible spending account * Health insurance * Life insurance * On-the-job training * Paid sick time * Paid time off * Parental leave * Vision insurance Work Location: In person
AXILLON AEROSPACE is a leading provider of complex, highly engineered composite and polymer solutions for demanding commercial and defense applications. Comprised of five, purpose-built centers of excellence throughout the USA and Mexico, each strategically focused on serving specific markets across aerospace engines and airframes, as well as munitions, radomes, antennas and fuel containment. JOB SUMMARY: Under limited supervision, the CNC Production Machine Operator performs standardized CNC machining operations and provides technical assistance to production associates and operations leadership as needed. ESSENTIAL DUTIES AND RESPONSIBILITIES: Assists in setting up complex production equipment and conducts tests, analyses and calibrates assemblies in accordance with company policy and safety procedures. Installs, maintains, repairs, rebuilds and operates a variety of machining tools including lathes, milling machines, drill presses, etc. Diagnoses problems, disassembles, determines extent of repair necessary or feasible, repairs, refits or replaces worn or defective parts and reassembles. Makes ordinary replacements of new parts and/or complete new assemblies and selects materials, plans and performs machining operations on new or replacement parts. Works to specifications, from both oral and written instructions, sketches, blueprints, engineering drawings and manuals with little supervision. Other responsibilities as assigned. Regular, consistent and punctual attendance is required. May need to work nights and weekends, variable schedule(s) and additional hours as necessary. JOB SPECIFICATIONS: Education: High School Diploma or equivalent. Certifications: Vocational training, apprenticeships or the equivalent experience in related field. Years Experience: 2-5 years or more of relevant experience. Skills: Experience in semi-repetitive specialized machine operations. Strong experience in machining tools Ability to use hand tools and machinery. Able to follow instructions, sketches, blueprints, engineering drawings and manuals. Capable of problem-solving: Exercises judgment, based on previous experience, practices and precedents, to identify and solve problems that arise with little or no precedent. Effective oral and written communication. Please note that the salary range information is only applicable for California. Compensation is based on variety of factors, candidate experience, qualifications, and location as well as market and business considerations. Pay Range: $25/hour - $32/hour. Axillon is committed to ensuring equal employment opportunities for all job applicants and employees. Employment decisions are based upon job related reasons regardless of race, ethnicity, color, religion, sex, sexual orientation, age, national origin, disability, gender identity, genetic information, veteran status, or any other status protected by law. This position is subject to meeting export compliance eligibility requirements. This position requires use of information which is subject to the International Traffic in Arms Regulations (ITAR). All applicants must be U.S. persons within the meaning of ITAR. ITAR defines a U.S. person as a U.S. Citizen, U.S. Permanent Resident (i.e. 'Green Card Holder'), Political Asylee, or Refugee.
VTI Life Sciences (VTI) is seeking forward-thinking and ambitious engineers looking to accelerate their career in the pharmaceutical, biotechnology and medical device industries. We offer an opportunity to help support our teams of industry subject matter experts and thought leaders while consulting with some of the biggest companies in the Life Sciences industry. We are looking for a Computer System Validation (CSV) Specialist with Industrial Automation Knowledge to be responsible for ensuring that computerized systems used in regulated environments are validated in compliance with industry standards, regulatory requirements (such as FDA 21 CFR Part 11 and 820, Data Integrity, ISO 13485 and GAMP 5.), and company policies. The role includes the development and execution of validation protocols, risk assessments, and documentation to support the lifecycle of cGxP systems.The successful candidates will provide hands-on validation and testing support for PLC and SCADA controlled manufacturing systems. This role requires strong knowledge of industrial controls, automation architecture, equipment functionality, computerized system validation, data integrity, and regulated manufacturing practices. RESPONSIBILITIES: Authoring and Executing Software Testing, FAT, SAT, IQ, OQ, and Test Method Validation protocols. Draft, route, and execute Commissioning and Qualification Protocols (CQ, IQ, OQ, PQ) with Final Report. Scheduling and execution of qualification activities Qualification data collection and analysis against acceptance criteria. Drafting and/or reviewing User Requirement Specifications/Software Requirement Specifications. Software Design Specification drafting and review. Documentation generation and updates (SOPs, PFMEA, Forms, etc.) Meeting attendance and project coordination. Provide all services in accordance with FDA cGxP guidelines and regulations. QUALIFICATIONS: Bachelor's degree or higher in Engineering, Life Sciences, or related discipline. 7+ years of... INDEED INTERNAL TEST JOB: Please note that this is a test job used to test the Indeed Apply production system. This is NOT A REAL JOB and you are requested not to apply for the job
VTI Life Sciences (VTI) is seeking forward-thinking and ambitious engineers looking to accelerate their career in the pharmaceutical, biotechnology and medical device industries. We offer an opportunity to help support our teams of industry subject matter experts and thought leaders while consulting with some of the biggest companies in the Life Sciences industry. We are looking for a Computer System Validation (CSV) Specialist with Industrial Automation Knowledge to be responsible for ensuring that computerized systems used in regulated environments are validated in compliance with industry standards, regulatory requirements (such as FDA 21 CFR Part 11 and 820, Data Integrity, ISO 13485 and GAMP 5.), and company policies. The role includes the development and execution of validation protocols, risk assessments, and documentation to support the lifecycle of cGxP systems.The successful candidates will provide hands-on validation and testing support for PLC and SCADA controlled manufacturing systems. This role requires strong knowledge of industrial controls, automation architecture, equipment functionality, computerized system validation, data integrity, and regulated manufacturing practices. RESPONSIBILITIES: Authoring and Executing Software Testing, FAT, SAT, IQ, OQ, and Test Method Validation protocols. Draft, route, and execute Commissioning and Qualification Protocols (CQ, IQ, OQ, PQ) with Final Report. Scheduling and execution of qualification activities Qualification data collection and analysis against acceptance criteria. Drafting and/or reviewing User Requirement Specifications/Software Requirement Specifications. Software Design Specification drafting and review. Documentation generation and updates (SOPs, PFMEA, Forms, etc.) Meeting attendance and project coordination. Provide all services in accordance with FDA cGxP guidelines and regulations. QUALIFICATIONS: Bachelor's degree or higher in Engineering, Life Sciences, or related discipline. 7+ years of relevant FDA-regulated industry experience. Expertise in regulatory requirements and guidance, including 21 CFR Part 11 and 820, Data Integrity, ISO 13485 and GAMP 5. Familiarity with Python and Test Scripts. 3+ years of proven experience with SQL, Software Validation and Computerized Systems Validation. Must have experience working in an FDA-regulated environment. Experience with Automation Equipment such as HMI's, Robotized Manufacturing Systems and Vision Sensors. Experience in manufacturing and testing of Medical Devices. Advanced knowledge of PLC programming concepts and industrial automation architecture. Hands-on experience with the Rockwell Automation suite and FactoryTalk View. Experience testing equipment alarms, error codes, interlocks, system messages, and abnormal operating conditions. Experience with databases, electronic records, part-traceability systems, and data-integrity principles. Proficiency in Microsoft Office including Word, Excel, PowerPoint, MS Project, Visio, etc. Exceptional technical writing, review and analytical skills. Knowledge of good documentation practices and cGMP. ASSIGNMENT REQUIREMENTS Must be local to San Diego and available to Travel to Canada for 2 to 3 weeks at the time (Travel Expenses Covered by the project) Strong performers may be considered for an extension beyond the initial project stage. SALARY RANGE FOR THIS ROLE IS $80,000 - $105,000 ANNUALLY FOR A W2 EMPLOYEE VTI Life Sciences strives to maintain and inspire professional excellence by providing Commissioning, Qualification, Quality Engineering, Automation and Validation Services to the Pharmaceutical, Biotechnology, Biologics and Medical Device industries. VTI offers professional development, training, competitive compensation, excellent benefits, a matching 401K, plus a stimulating and collaborative work environment. We are committed to providing exciting career opportunities in a work environment that values trust, respect, openness, teamwork, creative talent, enthusiasm and diligence. As one of the leading global Commissioning, Qualification and Validation Services organizations, VTI is always looking for innovative, talented and experienced validation professionals for our multinational and global offices. We offer some of the best salary and benefit packages in the industry for our full-time/permanent employees. www.validation.org 0bzd2rACO7
The Position Oceanside Operations (OCN) is a drug substance manufacturing organization dedicated to the reliable production of Roche’s commercial portfolio and pipeline products. Every year, OCN delivers millions of units of life-saving medicines to patients around the globe by leveraging its two integrated value streams: Stainless Steel and Single-Use production systems. As a Process Validation Engineer in our Manufacturing Sciences and Technology (MSAT) group, you will support cross-functional process validation strategies, lead regulatory documentation efforts, and ensure compliance across site-specific initiatives. This role serves as a structured professional growth pathway where you will gain hands-on exposure to core validation methodologies alongside senior engineers while driving continuous process improvements. The Opportunity Author, edit, and execute Process Validation (PV) protocols, execution reports, and regulatory deliverables (such as PPQ OneDoc, PAS, and IMA) in accordance with cGMP standards. Perform rigorous compliance and data-integrity checks on draft validation documents to ensure summary findings and data tables strictly align with raw supporting data. Collaborate with the PV Lead to maintain the master schedule and submission filings, actively tracking project milestones. Assist with technical activities for product introductions, process transfers, and capacity expansion efforts. Facilitate review and approval workflows across cross-functional teams (Quality, MSAT, Regulatory), keeping partners accountable to project timelines. Utilize digital quality systems (Veeva, Smartsheet, AppSheet) to track metrics and streamline documentation workflows. Support root-cause investigations for discrepancies, aiding in the design and implementation of corrective actions (CAPAs). Partner with senior engineers to gain hands-on experience executing equipment qualifications and cleaning validation studies. Who you are You hold a Bachelor’s degree in Chemical Engineering, Bioengineering, Life Sciences, or a related discipline with 4–6 years of relevant industry experience; OR a Master’s degree with 2–4 years of experience. You possess practical experience with process validation concepts, technical writing, regulatory submission support, and Quality Systems within a cGMP biopharmaceutical manufacturing environment. You have a strong foundational understanding of biopharmaceutical unit operations and process engineering principles. You bring exceptional attention to detail with demonstrated skill in technical formatting, compliance checks, and verifying raw source data. You are a strong communicator and proactive problem-solver who thrives when collaborating with cross-functional and global network partners. Preferred Familiarity with electronic document management systems such as Veeva Quality Docs/RIM, eVAL, or Smartsheet. Experience working comfortably within office and cGMP cleanroom environments requiring full gowning. Work Environment & Physical Demands Mix of office and cGMP cleanroom environments. Must be able to remain on feet/walk for extended periods (up to 8–10 hours). Lift up to 25lbs may be required. May work in the clean room environment that requires full gowning (scrubs, coveralls, gloves, safety glasses, and steel-toe boots); no makeup or jewelry permitted in processing areas.. Clean room environments feature large mechanical equipment, piping, and pumps connecting to tanks serviced by high-pressure steam, water and air together this creates a loud environment. Work with hazardous materials and chemicals. Ability to sit, stand and move within working city for extended periods. Relocation benefits are not available for this posting. The expected salary range for this position based on the primary location of California is $80,500 - $149,500. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Benefits Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants. JOB FACTS Job Sub Category Quality Schedule Full time Job Type Regular Posted Date Sep 28th 2026 Job ID 202609-123591
The Company Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock information and insights that drive better health outcomes. Here we are 25 years later, having pioneered an industry. And we're just getting started. We are broadening our vision beyond diabetes to empower people to take control of health. That means personalized, actionable insights aimed at solving important health challenges. To continue what we've started: Improving human health. We are driven by thousands of ambitious, passionate people worldwide who are willing to fight like warriors to earn the trust of our customers by listening, serving with integrity, thinking big, and being dependable. We've already changed millions of lives and we're ready to change millions more. Our future ambition is to become a leading consumer health technology company while continuing to develop solutions for serious health conditions. We'll get there by constantly reinventing unique biosensing-technology experiences. Though we've come a long way from our small company days, our dreams are bigger than ever. The opportunity to improve health on a global scale stands before us. Meet the Team Join a collaborative team responsible for supporting and improving the equipment, processes, and electronics that help drive Dexcom's manufacturing, engineering, and research and development operations. In this role, you will play a key part in maintaining reliable equipment performance, supporting innovative projects, and contributing to continuous improvement initiatives that help deliver life-changing technology to people living with diabetes. Where You Come In : You provide technical support for equipment, processes, and electronics used in Dexcom's Operations, Engineering, and Research & Development organizations. You troubleshoot, maintain, and improve production and development equipment to ensure safe, efficient, and reliable operation. You prepare, update, and maintain technical documentation, maintenance records, and associated reports. You support cross-functional teams by contributing to equipment development, testing, and continuous improvement initiatives. What Makes You Successful : You troubleshoot and repair equipment, process, and electronics issues while identifying and implementing improvements to enhance performance and reliability. You perform preventative maintenance activities and maintain accurate maintenance records, spare parts inventories, and equipment documentation. You work effectively with equipment manufacturers and vendors to ensure equipment remains safe, functional, and operating at optimal performance. You perform programming, integration, and technical support activities for automated equipment, processes, and electronic systems. You contribute to equipment, process, and electronics development projects by assisting with planning, purchasing, assembly, testing, and implementation activities. You work independently with minimal supervision while collaborating effectively with engineers, technicians, and cross-functional teams. You support team operations by assisting with coordination efforts, project activities, and group leader responsibilities as needed. You consistently follow safety procedures and perform all assigned work with a strong commitment to workplace safety and quality. Your strong problem-solving skills, technical aptitude, and continuous improvement mindset help drive operational excellence and project success. What you’ll get: A front row seat to life changing CGM technology. Learn about our brave #dexcomwarriors community . A full and comprehensive benefits program. Growth opportunities on a global scale. Access to career development through in-house learning programs and/or qualified tuition reimbursement. An exciting and innovative, industry-leading organization committed to our employees, customers, and the communities we serve. Travel Required: 0 - 24% Experience and Education Requirements: Typically requires a minimum of 4-6 years of related experience and High School diploma/certificate or equivalent. Please note: The information contained herein is not intended to be an all-inclusive list of the duties and responsibilities of the job, nor are they intended to be an all-inclusive list of the skills and abilities required to do the job. Management may, at its discretion, assign or reassign duties and responsibilities to this job at any time. The duties and responsibilities in this job description may be subject to change at any time due to reasonable accommodation or other reasons. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Dexcom’s AAP may be viewed upon request by contacting Talent Acquisition at [email protected]. If you are an individual with a disability and would like to request a reasonable accommodation as part of the employment selection process, please contact Dexcom Talent Acquisition at [email protected]. Meritain, an Aetna Company, creates and publishes the Machine-Readable Files on behalf of Dexcom. To link to the Machine-Readable Files, please click on the URL provided: https://health1.meritain.com/app/public/#/one/insurerCode=MERITAIN_I&brandCode=MERITAINOVER/machine-readable-transparency-in-coverage?reportingEntityType=TPA_19874&lock=true To all Staffing and Recruiting Agencies: Our Careers Site is only for individuals seeking a job at Dexcom. Only authorized staffing and recruiting agencies may use this site or to submit profiles, applications or resumes on specific requisitions. Dexcom does not accept unsolicited resumes or applications from agencies. Please do not forward resumes to the Talent Acquisition team, Dexcom employees or any other company location. Dexcom is not responsible for any fees related to unsolicited resumes/applications. AI in Hiring Notice: We may use AI supported tools to help make our hiring process more efficient, consistent, and accessible for candidates around the world. All hiring decisions are made by people. Salary: $21.49 - $32.25 #DexcomUS
The Company Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock information and insights that drive better health outcomes. Here we are 25 years later, having pioneered an industry. And we're just getting started. We are broadening our vision beyond diabetes to empower people to take control of health. That means personalized, actionable insights aimed at solving important health challenges. To continue what we've started: Improving human health. We are driven by thousands of ambitious, passionate people worldwide who are willing to fight like warriors to earn the trust of our customers by listening, serving with integrity, thinking big, and being dependable. We've already changed millions of lives and we're ready to change millions more. Our future ambition is to become a leading consumer health technology company while continuing to develop solutions for serious health conditions. We'll get there by constantly reinventing unique biosensing-technology experiences. Though we've come a long way from our small company days, our dreams are bigger than ever. The opportunity to improve health on a global scale stands before us. Meet the team: Test Lab supports Dexcom internal customers including quality, process engineering, clinical trials, and R&D by providing testing and related data to make critical product decisions. The team executes a high variety of testing which includes visual inspections, measurements, mechanical/destructive testing, and wet lab testing. Working with the Test Lab team, you can expect exposure to each of these teams and understand how Dexcom ensures a great product is made for our patients! Where you come in: You will execute a wide variety of testing in a laboratory setting and make detailed observations while performing tasks You will follow laboratory protocols, test procedures, and chemical safety guidelines You will maintain laboratory equipment, glassware, and inventory levels of consumable supplies You will assist with testing traceability by filing, recordkeeping, and entering data into datasheets and databases You will support the processing of large data sets using set programs and macros You will perform limited troubleshooting for laboratory equipment You will assist with test method validations and GRR testing You will support process qualification testing You will ideate and execute continuous improvement projects to improve the lab You will maintain 6S best practices What makes you successful: You have experience in a lab environment; should include experience in mechanical and/or wet lab testing You bring an eye for safety. Maintaining a safe environment for you and others as well as finding opportunities to improve lab safety You understand how to follow and edit written procedures for commercial use You have experience speaking effectively with large groups, customers and team members Preferred: You have lean six sigma certification Preferred: You have experience using macros for data analysis What you’ll get: A front row seat to life changing CGM technology. Learn about our brave #dexcomwarriors community . A full and comprehensive benefits program. Growth opportunities on a global scale. Access to career development through in-house learning programs and/or qualified tuition reimbursement. An exciting and innovative, industry-leading organization committed to our employees, customers, and the communities we serve. Travel Required: 0-5% Experience and Education Requirements: Typically requires a minimum of 2-4 years of related experience and a High School diploma/certificate or equivalent. Please note: The information contained herein is not intended to be an all-inclusive list of the duties and responsibilities of the job, nor are they intended to be an all-inclusive list of the skills and abilities required to do the job. Management may, at its discretion, assign or reassign duties and responsibilities to this job at any time. The duties and responsibilities in this job description may be subject to change at any time due to reasonable accommodation or other reasons. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Dexcom’s AAP may be viewed upon request by contacting Talent Acquisition at [email protected]. If you are an individual with a disability and would like to request a reasonable accommodation as part of the employment selection process, please contact Dexcom Talent Acquisition at [email protected]. Meritain, an Aetna Company, creates and publishes the Machine-Readable Files on behalf of Dexcom. To link to the Machine-Readable Files, please click on the URL provided: https://health1.meritain.com/app/public/#/one/insurerCode=MERITAIN_I&brandCode=MERITAINOVER/machine-readable-transparency-in-coverage?reportingEntityType=TPA_19874&lock=true To all Staffing and Recruiting Agencies: Our Careers Site is only for individuals seeking a job at Dexcom. Only authorized staffing and recruiting agencies may use this site or to submit profiles, applications or resumes on specific requisitions. Dexcom does not accept unsolicited resumes or applications from agencies. Please do not forward resumes to the Talent Acquisition team, Dexcom employees or any other company location. Dexcom is not responsible for any fees related to unsolicited resumes/applications. AI in Hiring Notice: We may use AI supported tools to help make our hiring process more efficient, consistent, and accessible for candidates around the world. All hiring decisions are made by people. Salary: $21.49 - $32.25 #DexcomUS
General Atomics Aeronautical Systems, Inc. (GA-ASI), an affiliate of General Atomics, is a world leader in proven, reliable remotely piloted aircraft and tactical reconnaissance radars, as well as advanced high-resolution surveillance systems. The Production Engineer will serve as a senior technical expert providing production support and sustainment engineering across all GA-ASI product lines. This role requires extensive knowledge of airframe systems, composite structures, configuration management, and Material Review Board (MRB) processes. The position will interface with multiple engineering disciplines, manufacturing, quality, and field service organizations to resolve complex technical issues and support production operations. JOB DUTIES & RESPONSIBILITIES Provide expert-level engineering support for production operations across all GA-ASI product lines Lead and support continuous improvement events for production processes across all GA-ASI product lines to improve producibility, efficiency, and quality Investigate nonconformances and determine impact on next level assemblies for proper Quality Notification (QN) and Supplier Deviation Request (SDR) disposition Lead root cause corrective action (RCCA) investigations using methodologies such as fishbone diagrams and DMAIC Execute redline processes and provide build support for production and pre-production programs Create and review design-driven Change Requests (CR) and act as subject matter expert during Change Control Board (CCB) reviews Provide configuration change dispositions for in-work, in-stock, and sold-off parts Incorporate Change Notification packages utilizing CAD software and PLM systems Support design and manufacturing readiness reviews to ensure manufacturability and proper tolerance stack-up Collaborate with Stress Analysis, Airframe Design, Materials, and Process Engineering to resolve technical issues We recognize and appreciate the value and contributions of individuals with diverse backgrounds and experiences and welcome all qualified individuals to apply. Job Qualifications Typically requires a bachelors degree, masters degree or PhD in engineering or a related technical discipline from an accredited institution and progressive engineering experience as follows; six or more years of experience with a bachelors degree, four or more years of experience with a masters degree, or two or more years with a PhD. May substitute equivalent engineering experience in lieu of education. Must have a complete understanding of engineering concepts, principles, codes, and theory; experience demonstrating a broad application of those concepts; and, expanding knowledge of principles, concepts, theory, and practices in related technical specialties. Must possess the ability to understand new concepts quickly; apply them accurately throughout an evolving environment; organize, schedule, and coordinate work phases; and, determine the appropriate approach at the task level or, with assistance, at the project level to provide solutions to a range of complex problems. Must have excellent communication, computer, documentation, presentation, and interpersonal skills, ability to work independently and as part of a team; able to perform complex tasks in one engineering area; and, lead a team of less experienced professional employees on semi-routine tasks. Able to work extended hours as required. A Professional Engineering License is desirable. Technical Skills: Experience with PLM systems (Windchill, TeamCenter, or similar) Knowledge of ERP systems (SAP, Great Plains, or similar) Knowledge of CAD software (SolidWorks, Creo Parametric, AutoCAD, or similar) Understanding of GD&T principles per ASME Y14.5 Other Requirements: Strong analytical and problem-solving skills Excellent written and verbal communication abilities Ability to work effectively across multiple disciplines and organizations Ability to obtain and maintain security clearance as required Job Category Manufacturing Experience Level Mid-Level (3-7 years) Workstyle Onsite Full-Time/Part-Time Full-Time Salary Pay Range Low 99,500 Pay Range High 170,750 Travel Percentage Required 0% - 25% Relocation Assistance Provided? No US Citizenship Required? Yes Clearance Required? Desired Clearance Level Secret Search Jobs at | General Atomics and Affiliated Companies
Inovar Packaging Group, LLC Company, is proud to be one of North America’s premier flexographic and digital printing companies, dedicated to the success of our employees and customers. We invest in the latest equipment and technology, continually seeking the best strategies and solutions to deliver cutting-edge, top-quality products to our clients. Our culture is customer-driven, team-oriented, and built on win-win partnerships. Why Join Us? Competitive pay and performance-based bonus program Comprehensive benefits package including medical, dental, vision, life insurance, and short/long-term disability Company Equity 401(k) Retirement Plan with a generous company match Paid Time Off (PTO) Tuition Assistance Career advancement opportunities within a rapidly growing organization Job Summary We are seeking a 2nd Shift Production Supervisor to oversee our production operations. This role ensures smooth and efficient manufacturing processes by effectively monitoring employees, organizing workflows, and driving productivity in a fast-paced label production environment. The ideal candidate will be highly competent, capable of managing complex operations, and skilled at optimizing day-to-day activities while maintaining cost efficiency. The ultimate goal is to deliver high-quality products while maximizing profitability. Key Responsibilities Responsibilities Set and communicate daily, weekly, and monthly objectives to employees. Supervise and evaluate staff performance to ensure goals are met or exceeded. Organize workflow by assigning responsibilities and preparing production schedules. Provide coaching, technical leadership, and training in areas such as: Press setup/operation Testing and tooling Troubleshooting Machine metrics reporting Changeover processes Safety procedures Record keeping Ensure the safe operation of equipment and schedule regular maintenance. Conduct first article quality control (QC) checks to confirm printed and finished products meet job-ticket specifications. Prepare and submit performance and progress reports as required. Identify and address inefficiencies, recommending process improvements. Enforce safety guidelines and uphold company values and standards. Promote accurate job costing by fostering a culture of precise time and material tracking for each job-ticket. Exhibit strong leadership and supervisory skills, including: Training and developing teammates for roles with increased responsibilities. Providing constructive feedback to improve individual and team performance. Conduct daily shift meetings to discuss safety, produ Requirements Proven experience as a Production Supervisor or Production Lead. Proficiency in operating various types of manufacturing machinery and tools. Strong organizational and leadership abilities. Excellent communication and interpersonal skills. Self-motivated with a results-driven mindset. Effective problem-solving skills. High school diploma required; a degree in a technical, engineering, or related field is preferred. At Inovar, our values of Customer Focused, Partnership Driven, and Team Engagement guide how we work with our customers and with one another. Inovar Packaging Group is an Equal Opportunity Employer. We are committed to creating an inclusive environment for all employees and applicants. All qualified individuals will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, age, national origin, disability, veteran status, or any other protected characteristic under applicable law.