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*Job Summary* We are seeking a dedicated and detail-oriented Manufacturing Associate to join our dynamic team. In this role, you will be responsible for supporting various manufacturing processes and ensuring the efficient production of high-quality products. The ideal candidate will possess a strong work ethic, attention to detail, and the ability to work collaboratively in a fast-paced environment. *Duties* * Aseptic cell culture * Stem cell passaging, Harvest. * Operate and monitor production activities, machinery and equipment to ensure optimal performance. * Assemble products according to specifications and quality standards. * Conduct routine inspections of products and equipment to identify any defects or issues. * Maintain a clean and organized work area, adhering to safety protocols and regulations. * Assist in the training of new team members on manufacturing processes and equipment operation. * Collaborate with team members to meet production goals and deadlines. * Document production activities accurately, including quantities produced and any issues encountered. *Requirements* * High school diploma or equivalent preferred. * Aseptic cellular processing * Class 7 Gowning * BSC work * Previous experience in a manufacturing or production environment is a plus but not required. * Ability to operate machinery and tools safely and effectively. * Strong attention to detail with a commitment to quality workmanship. * Ability to lift up to 50 pounds and stand for extended periods. * Excellent communication skills and the ability to think and problem solve. * Strong problem-solving skills with a proactive approach to addressing challenges within the cGMP framework. Join our team as a Manufacturing Associate and contribute to our mission of delivering exceptional products while growing your skills in a supportive environment. Job Type: Full-time Pay: $33.00 - $36.00 per hour Benefits: * 401(k) * Dental insurance * Health insurance * Life insurance * Paid time off * Vision insurance People with a criminal record are encouraged to apply Experience: * CGMP: 1 year (Preferred) * Cell culture: 1 year (Preferred) Ability to Commute: * Poway, CA 92064 (Required) Ability to Relocate: * Poway, CA 92064: Relocate before starting work (Required) Work Location: In person
*Digital Force Technologies (DFT)* is a defense technology provider with a 20-year history of developing and fielding advanced sensor systems, force protection solutions, and tactical surveillance products. DFT’s extensive history of innovation, in-house expertise, and robust network of technology partners allows DFT to rapidly addresses critical Department of Defense (DoD) and Federal Agency requirements. DFT’s engineering team is a diverse and skilled group, determined to develop advanced technical solutions. DFT offers a unique chance to develop and work with modern technologies while delivering impact and seeing products grow from concept to reality. DFT is a results driven culture focused on innovation, creativity, and growth. If you have a passion for solving complex problems, making an immediate impact on a dynamic, and fast moving, product development team, we’d love to hear from you! *What We Need:* DFT is searching for a skilled and experienced *Electro-Mechanical Technician* that is responsible for assembling, installing, repairing, upgrading and testing electronic and computer-controlled mechanical systems. The ideal candidate will enjoy learning new things, be flexible in a fast-pace environment, and will build positive relationships with both internal and external customers. The ideal candidate will have significant aptitude and help make the team around them better. *What You’ll Do:* * Perform all aspects of electrical and mechanical assembly and testing of prototypes, box builds, cables, and other products and systems (assembly, cable and board soldering). * Work closely with Electrical, Mechanical, and Test Engineers with all necessary testing, debugging, rework, and improvement of products, designs, and work instructions. * Collaborate with team to drive continuous improvement in the department. * Perform other production tasks as needed including kitting, inspecting, and preparing products for shipment. * Works from written procedures, schematics, blueprints, diagrams and / or visual work instructions. * Troubleshoot and repair PCB’s, box builds, cables, etc. * Other duties as assigned. *Required Skills/Qualifications:* * High School Diploma or equivalent. * 10+ years of relevant experience in electro-mechanical assembly. * Proficient in Microsoft Office applications (Outlook, Excel, Word, etc.). * Previous experience working with ERP systems. * Familiarity and experience using oscilloscopes, voltmeters, point-to-point continuity testers, and bridges. * Knowledge and use of hand tools. * Knowledge and experience of ESD best practices. * Current or previous CERTIFICATION for soldering (IPC-A-610, IPC-A-620, J-STD-001, etc.). * Must be able to obtain and hold a U.S. security clearance. *Preferred Qualifications:* * Experienced user of Microsoft Office suite. * Excellent organizational skills to maintain flow of work within the unit. * Strong interpersonal, verbal and written communication skills to interface with all levels of internal employees and to accurately document and report. * Previous LEAN training or certifications. *What We Offer:* *Salary Range, $30/hr - $36/hr* The salary range for this role is an estimate based on a wide range of compensation factors, inclusive of base salary only. Actual salary offer may vary based on (but not limited to) work experience, education and/or training, critical skills, and/or business considerations. *EEOC Statement - *_DFT is an equal-opportunity employer, and we encourage candidates from all backgrounds to apply. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability or protected veteran status._ DFT offers a comprehensive benefit package including medical, dental, vision, 401K w/ company match, life insurance, short term disability, 3 weeks PTO, 13 company holidays, and much more. In addition, DFT provides a company culture that encourages: * Collaboration * Innovation * Employee engagement * Motivation *If you are looking for a dynamic place to work where your contribution makes a difference in supporting the mission, DFT is the right company for you.* Job Type: Full-time Pay: $30.00 - $36.00 per hour Benefits: * 401(k) * 401(k) matching * Dental insurance * Employee assistance program * Flexible schedule * Flexible spending account * Health insurance * Health savings account * Life insurance * Paid time off * Vision insurance Application Question(s): * Do you have the ability to attain and maintain a security clearance? Experience: * Soldering: 5 years (Required) Ability to Commute: * San Diego, CA 92121 (Preferred) Ability to Relocate: * San Diego, CA 92121: Relocate before starting work (Required) Work Location: In person
Test Engineer / Technician – Quality Control REVA Medical – San Diego, CA Full-Time | On-site REVA Medical is pioneering bioresorbable vascular scaffolds and innovative combination products to transform the treatment of coronary artery disease. We are looking for a Test Engineer / Technician – Quality Control to join our growing Quality team. This is a hands-on role focused on mechanical and functional testing of medical devices to support timely batch release. It's an excellent opportunity for an early-career engineer or an experienced technician who wants to develop deep expertise in medical device quality systems in a fast-paced startup environment. Key Responsibilities Perform hands-on mechanical, visual, and functional testing of raw materials, components, in-process assemblies, and finished devices. Execute testing according to engineering drawings, manufacturing instructions, and approved test procedures under cGMP compliance. Support first article inspections, test method development, and test method validations. Accurately document and maintain inspection and test records in the quality system. Identify and report deviations or nonconformances and assist with investigations. Help maintain lab equipment through calibration, preventive maintenance, and basic troubleshooting. Keep the testing and inspection areas clean, organized, and compliant with safety standards. Collaborate with the QC Manager and cross-functional teams to ensure high-quality and timely product release. Qualifications Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or a related field with 0–2 years of experience, OR High school diploma/GED with 5+ years of hands-on experience in miniature parts, mechanical, or microscopic inspection in a regulated environment (ISO 9000, medical device, or similar). Strong experience using calipers, micrometers, optical measurement systems, tensile testers, or other precision inspection tools. High level of manual dexterity and exceptional attention to detail. Ability to read and interpret engineering drawings and follow detailed test procedures. Excellent written and verbal communication skills. Experience with catheters, stents, or interventional cardiology devices is a strong plus. Familiarity with cGMP and quality system requirements is preferred. What We Offer Opportunity to work on cutting-edge bioresorbable technologies that improve patient lives. Hands-on experience in a growing medical device company. Collaborative and supportive startup culture. Competitive compensation and benefits package. Please note: Relocation assistance and visa sponsorship are not available for this role.
At Fluor, we are proud to design and build projects and careers. We are committed to fostering a welcoming and collaborative work environment that encourages big-picture thinking, brings out the best in our employees, and helps us develop innovative solutions that contribute to building a better world together. If this sounds like a culture you would like to work in, you’re invited to apply for this role. Job Description This position assists and supports others in a department, subdivision, function, or project. The position relies primarily on established policies, procedures, and applicable work practices to make decisions as they apply to the job duties and responsibilities. Under general supervision, this position operates complex building controls systems and executes commissioning, startup, and operational plans. This requires following best working practices and operating procedures to ensure safe and efficient operations of equipment. • Comply with all key work processes required by the company and documents any deficiencies • Perform and train others to perform plant operations in a safe, incident free, reliable manner while identifying opportunities to reduce costs, increase productivity, and most importantly, continually reduce the risk of accidents and injuries • Participate in job specific training, presentations, modules, qualification tests require to perform work and qualify for job rotations • Identify, document, and monitor key operating parameters; ensure data and forms are filed, retained, and distributed as required by plant practices • Ensure handovers among operators are thorough and clearly communicated and documented • Identify and track efficiency data associated with key operational activities; submit improvement ideas and support their adoption and implementation • Provide timely assistance to other plant operators when required • Maintain a clean and organized operating area • Maintain compliance with all applicable policies, procedures, and global standards • Plan, organize, and carry out assignments as directed • Adhere to and support Fluor’s Health, Safety & Environmental and Sustainability Policies • Effectively develop and apply the Core Skills to the job • Meet expectations on attendance and punctuality • Other duties as assigned Basic Job Requirements • A combination of education and directly related experience equal to four (4) years. Some locations may have additional or different qualifications in order to comply with local regulations • Ability to communicate effectively with audiences that include but are not limited to management, coworkers, clients, vendors, contractors, and visitors • Job related technical knowledge necessary to complete the job • Ability to attend to detail and work in a time-conscious and time-effective manner Other Job Requirements • Must have knowledge and experience of plant operations including aspects of planning, training, scheduling, safe work practices and incident free operations • Must have excellent verbal and written English communications skills Preferred Qualifications • Must have a technical diploma or technical college certificate or global equivalent • Minimum of five (5) years of experience in positions supporting plant operations or maintenance; having plant operating experience in a manufacturing environment is essential while having operational board experience is preferred • Work effectively with multi-cultural personnel to execute work assignments • Strong interpersonal and mentoring skills and organizational accountability processes • Good multi-tasking skills • Proficient in MS-Office programs We are an equal opportunity employer. All qualified individuals will receive consideration for employment without regard to race, color, age, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, genetic information, or any other criteria protected by governing law. Benefits Statement: Fluor is proud to offer a comprehensive benefits package designed to promote employee health, wellness, and financial security. Our offerings include medical, dental and vision plans, EAP, disability coverage, life insurance, AD&D, voluntary benefit plans, 401(k) with a company match, paid time off (personal, bereavement, sick, holidays) for salaried employees, paid sick leave per state requirement for craft employees, parental leave, and training and development courses. Market Rate Statement: The market rate for the role is typically at the mid-point of the salary range; however, variations in final salary are determined by additional factors such as the candidate’s qualifications, relevant years of experience, geographic location, internal pay equity, and prevailing market conditions for the specific role. Notice to Candidates: Background checks are carried out as part of any conditional offer made, including (but not limited to & role dependent) education, professional registration, employment, references, passport verifications and Global Watchlist screening. To be Considered Candidates: Must be authorized to work in the country where the position is located. Salary Range: $57,500.00 - $107,500.00
Manager, Quality Control REVA Medical – San Diego, CA Full-Time | On-site REVA Medical is pioneering next-generation bioresorbable vascular scaffolds and combination products to transform the treatment of coronary artery disease. We are seeking a hands-on Manager, Quality Control to lead our QC laboratory operations and play a critical role in ensuring the quality and timely release of our innovative medical devices. About the Role As the Manager, Quality Control, you will lead day-to-day QC laboratory operations supporting both development and commercial manufacturing. This is a leadership role that combines technical expertise, process development, and team management in a fast-paced startup environment. Key Responsibilities Lead all QC laboratory activities, including analytical and mechanical testing of raw materials, in-process, and finished combination products. Ensure timely and accurate testing to support batch release and product disposition. Review and approve test records, documentation, and partner with QA for final lot release decisions. Build and optimize scalable QC processes, including sample management, SOPs, testing schedules, and lab systems. Transfer and implement new test methods from R&D, including method validation. Monitor and trend QC data to drive product and process improvements. Lead investigations for nonconformances and ensure timely resolution. Hire, train, develop, and lead a high-performing QC team in a collaborative, high-accountability culture. Maintain inspection readiness and actively support FDA and other regulatory audits. Qualifications Bachelor's degree in Chemistry, Biology, Engineering, or a related scientific discipline (Master's preferred). 7–10+ years of Quality Control experience in medical device, pharmaceutical, or combination product environments. Prior experience leading or managing a QC team in a GMP-regulated setting. Strong hands-on experience with analytical and mechanical testing methods. Proven track record supporting FDA inspections and maintaining cGMP compliance. Experience with combination products (device + drug) is strongly preferred. Background in interventional cardiology products (drug-eluting stents, balloon catheters, scaffolds, etc.) is a plus. Key SkillsAttributes Strong leadership and people management skills. Excellent organizational, planning, and process improvement abilities. Skilled in SOP development, root cause analysis, and cross-functional collaboration. Comfortable operating in a fast-paced, evolving startup environment. What We Offer Opportunity to make a direct impact on groundbreaking cardiovascular technologies. Competitive compensation and benefits package. Collaborative, mission-driven culture in a growing company. If you are a detail-oriented leader who thrives in building scalable QC systems and wants to contribute to life-changing medical innovation, we'd love to hear from you.
Process Engineer I – Engineered Technical Ceramics Full Time + Benefits (Medical, Dental, Vision, 401k with Company Match, PTO) Job Type: Onsite Salary Range: $78,600 - $90,300 DOE Location: Poway, CA Fralock is an engineered solutions provider of specialty components and subassemblies using advanced materials for high reliability, severe environment, and technically challenging applications. We develop and manufacture custom integrated solutions. Established in 1967, we are a critical solutions provider to Fortune 500 corporations, government, and targeted OEMs in a variety of industries including Semiconductor Equipment Manufacturing, Medical and Life Science, Aerospace and Defense, Industrial, Electronics, and Energy. Fralock is headquartered in Valencia, CA with manufacturing locations located throughout Northern and Southern California. VISION To be recognized by our customers as a leading solutions provider of proprietary engineered advanced materials for high reliability, severe environment, and technically challenging applications. MISSION To create value, profitably grow, and share our success with all stakeholders. CULTURE Respect – We treat others the way they want to be treated. Integrity – We practice a high standard of ethics in our business dealings with customers, suppliers and employees. Responsiveness – We have a sense of urgency in responding to internal and external requests and work proactively to solve problems. Excellence/Competence – We empower our people to continuously improve and execute high quality work. Teamwork – We work together to achieve Fralock business objectives by communicating at a high level, by listening and having clarity in our expectations of one another. Individual Accountability and Personal Responsibility – We do what we have committed to do when we committed to doing it. Continuous Improvement across all segments of the company This position requires access to information controlled under the International Traffic in Arms Regulations (ITAR) or the Export Administration Regulations (EAR), the successful candidate must be a "U.S. person" as defined in the ITAR and EAR (which generally means (i) be a citizen or national of the United States; or (ii) be a lawful permanent resident of the United States; or (iii) have been admitted to the United States as a refugee, or have been granted asylum, as specified under applicable law. Job Summary Fralock is seeking a materials engineer or process engineer with 0-2 years of experience in product development and process/manufacturing engineering to join our team in Poway, CA. The process engineer I role is responsible for technical/operational ownership of complex development programs within guidance from senior engineering and product/program management. The Process Engineer I will collaborate and support key projects focused on evaluating process capability and stability for slip casting, paste formulation, sintering, detailed assembly and inspection equipment. This key hire will report to the Poway site engineering leadership while working and collaborating closely with Engineering, Quality, and Operations Managers to ensure the overall success of this growing segment of business at Fralock. Key Responsibilities Supports new product introduction (NPI) programs on behalf of product management, production and engineering. Participates in design reviews and contributes technical expertise for product feasibility and ideal manufacturing methods and implementation to design engineering. Owns development of project planning documents, including project/program scheduling, test plans and resource planning. Assist with formulating and improving travelers using operator provided data, making changes in ERP software. In timely manner, collaborate with quality and manufacturing resources to determine defect root causes, propose and implement corrective actions (immediate, and longer term) and document any manufacturing changes via travelers (operator, supervisors, managers). Evaluate manufacturing process capability (SPC), methods and tooling, applying Lean and Six Sigma principles. Responsible for monitoring furnace process performance, thermal consistency, shrink variability, and dye check yields. Editing and adjusting work instructions and/or process parameters as needed. Responsible for material lot release process testing, evaluating, and tracking material key properties for ceramic products. Work with engineering, operations and vendors to develop cost estimates and proposals Responsible for assisting and troubleshooting existing manufacturing processes Lead realization of work instructions and training for key selected processes Support tactical projects resulting from customer RMAs or audit findings, working to understand their root cause, to improve/amend documentation and procedures Required Skills Strong computer skills Excellent verbal and written communication skills Ability to analyze data and problem solve Ability to read and interpret engineering drawings Knowledge and application of failure mode analysis techniques as applied to both process development and process improvement Ability to realize and implement Design of Experiments to improve process capabilities Ability to use hand tools such as micrometer, calipers, and Archimedes scales. Pa Preferred Skills Self motivated, results and action oriented, and a strong team player A hands on aptitude Process Engineering knowledge Experience in ceramic and/or glass component manufacturing Ceramic powder handling and process in knowledge Experience with multilayer ceramic manufacturing Experience with high temperature material interactions and sintering Demonstrated history of running self-directed projects, managing timelines and executing projects in an R&D environment. CAD/CAM software experience and proficiency Experience interpreting FEA/CFD results Hands-on mechanical and/or thermophysical measurement testing experience Familiarity with navigating ERP and QMS systems to locate data Knowledge of Lean Manufacturing, Just In-Time, Kanban principles Knowledge of ISO 9001, AS9100 or ISO 13485 Experience Requirements 0-2 years in a technical engineering role Experience in one or more related engineering areas: ceramics manufacturing, sintering, industrial, production, or quality Education Requirements Bachelor’s degree in Materials Science and Engineering preferred or an Engineering related discipline. All offers of employment at Fralock are contingent upon clear results of a background check. Background checks may include some or all the following depending on job title and responsibilities: Social Security Verification Prior Employment Verification Criminal History Personal and Professional References Motor Vehicle Records Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of a position. Fralock provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
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 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 talentacquisition@dexcom.com. 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 talentacquisition@dexcom.com. 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. Salary: $21.49 - $32.25
As a Quality Programs Manager 4, you will be a key leader responsible for ensuring regulatory compliance, driving continuous improvement, and embedding industry best practices across our Quality Management System (QMS). You will lead and manage cross-functional quality and compliance initiatives, working collaboratively with stakeholders across Quality, Regulatory Affairs, R&D, Operations, Manufacturing Engineering, Supply Chain, Procurement, Marketing, and Corporate Quality to achieve organizational objectives. In this pivotal role, you will harmonize quality processes across sites and business units, define clear program objectives and metrics, and proactively manage risks. You will own quality planning documentation, champion process analysis and optimization, and play a central role in regulatory inspection readiness and response. Your leadership will foster transparent communication, program success, and a culture of excellence. Knowledge In-depth understanding of FDA Quality Management System Regulations (QMSR), ISO 13485, ISO 14971, and related medical device and IVD regulatory requirements. Proficiency in quality improvement tools and methodologies, including CAPA, Health Hazard Analysis/Assessment (HHA/HRA), Health Hazard Evaluation (HHE), MRB, and SCAR. Direct experience implementing and managing Quality Management Systems in the medical device or in-vitro diagnostic industry. Advanced knowledge of project and program management methodologies, frameworks, and best practices. Familiarity with digital quality solutions such as eQMS, analytics platforms, and project management software. Skills Proven ability to lead, harmonize, and execute complex, cross-functional quality and compliance programs across multiple divisions, sites, and regions. Strong analytical and critical thinking skills to evaluate risks, issues, and trade-offs, with the ability to make sound recommendations. Advanced project management skills, including defining scope, scheduling, resource planning, and maintaining program metrics and KPIs. Proficient in preparing and presenting data-driven insights, dashboards, and executive summaries to leadership. Exceptional organizational skills and attention to detail, with the ability to manage multiple priorities and projects. Expertise in stakeholder engagement, communications, and facilitating effective meetings (e.g., kickoffs, risk reviews, pre-inspection meetings). Experience developing and delivering training on advanced quality and regulatory topics. Behaviors Collaborative leader who builds strong partnerships across business units and functions. Proactive and strategic, anticipating risks and implementing effective mitigation strategies. Change agent who drives adoption of harmonized processes and a culture of continuous improvement. Transparent and effective communicator, able to engage stakeholders at all levels with clarity and credibility. Committed to ongoing professional development and knowledge transfer. Data-driven and focused on achieving measurable results and compliance excellence. Experience Bachelor’s degree in a technical or related field (Science, Engineering, or similar required). PMP certification or equivalent formal project/program management credential required. 10+ years of experience in Quality, Compliance, or related functions, preferably within the in-vitro diagnostic or medical device industry. Demonstrated track record of leading complex, cross-functional quality and compliance programs. Experience supporting and driving PMO and Quality improvement initiatives, including defining and refining standards, processes, and tools. Proven ability to mentor and develop quality and project management professionals. Participation in third-party QMS inspections and audit response activities.
Location: [Company Location] FLSA Status: Non-Exempt Job Summary: The Production Operator Level 1 is responsible for operating and maintaining production equipment to ensure efficient and safe manufacturing processes. This role involves performing routine tasks, monitoring equipment, and ensuring product quality. The Production Operator Level 1 will work closely with other team members to meet production goals and maintain a clean and safe work environment. Key Responsibilities: Operate and monitor production equipment to ensure efficient and safe manufacturing processes. Perform routine maintenance and cleaning of equipment. Conduct quality checks on products to ensure they meet specifications. Follow standard operating procedures and safety guidelines. Report any equipment malfunctions or safety concerns to the supervisor. Maintain accurate production records and logs. Assist with material handling and inventory management. Participate in continuous improvement initiatives to enhance productivity and efficiency. Collaborate with team members to achieve production targets. Qualifications: High school diploma or equivalent. Previous experience in a manufacturing or production environment preferred. Basic mechanical skills and ability to operate production equipment. Strong attention to detail and commitment to quality. Ability to follow instructions and work independently. Good communication and teamwork skills. Willingness to work flexible hours, including shifts and weekends. EEO Statement: [Company Name] is an equal opportunity employer committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. [Company Name] makes hiring decisions based solely on qualifications, merit, and business needs at the time.
What if the work you did every day could impact the lives of people you know? Or all of humanity? At Illumina, we are expanding access to genomic technology to realize health equity for billions of people around the world. Our efforts enable life-changing discoveries that are transforming human health through the early detection and diagnosis of diseases and new treatment options for patients. Working at Illumina means being part of something bigger than yourself. Every person, in every role, has the opportunity to make a difference. Surrounded by extraordinary people, inspiring leaders, and world changing projects, you will do more and become more than you ever thought possible. We're seeking a driven and talented Validation Engineer to support manufacturing operations through close collaboration with cross‑functional partners. This role is critical in defining, implementing, and maintaining validation activities that ensure robust, compliant manufacturing processes and systems. The ideal candidate brings experience in quality engineering, process development, or process engineering, and can quickly develop while working independently within a fast‑paced, team‑oriented environment. As a Validation Engineer, you will play a key role in driving overall quality performance and compliance by leading validation deliverables and activities across manufacturing systems and processes. Responsibilities: Represent the Consumable Validation group as the validation subject matter expert in manufacturing operations value streams and project teams, ensuring validation requirements and deliverables are communicated to the teams. Develop and articulate robust strategies for validation of processes and systems through development and release of holistic validation plans. In collaboration with end users, process owners, quality engineers and other team members, develop validation protocols and oversee execution of IQ, OQ, PQ for manufacturing processes and systems. Write reports summarizing results and statistics for all equipment and process validation projects. Be accountable for timely completion of all validation deliverables in accordance with manufacturing needs and project timelines. Learn and understand the applicable technology and engage in technical discussions. Provide consultation to other departments performing validation activities. Provide input for creation of requirements documents. Actively participate in creation of risk management documents such as pFMEA for systems and processes. Perform job function in compliance with the internal procedures and applicable external regulations and standards, e.g. FDA QSR, ISO-13485. Initiate and execute controlled document change requests. Execute other related tasks assigned by the supervisor. Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs. Experience: 1-2 years of related Validation experience in the life science industry (i.e. medical device/IVD, pharmaceutical, biotech) is preferred. Knowledge and working application of FDA and cGMP requirements. Knowledge and working application of validation principles and guidelines and industry practice, FMEA, and Risk Management. Knowledge and application of statistical techniques as a decision-making tool and practical experience in use of statistical analysis software JMP highly desirable. Knowledge and working application of standard operating procedures. Demonstrated ability to accomplish goals in collaboration with cross-functional teams. Demonstrated analytical problem-solving skills. Computer competency in MS Office. Excellent interpersonal, written, and verbal communication skills. Adaptable to fast-paced, dynamic work environment with ability to manage projects methodically. ValGenesis eVLMS and Teamcenter PLM experience is a plus. Education: Requires a bachelor’s degree or master’s degree in engineering or science. 1-2 years of related experience is preferred. The estimated base salary range for the Validation Engineer 1 role based in the United States of America is: $62,900 - $94,300. Should the level or location of the role change during the hiring process, the applicable base pay range may be updated accordingly. Compensation decisions are dependent on several factors including, but not limited to, an individual’s qualifications, location where the role is to be performed, internal equity, and alignment with market data. Additionally, all employees are eligible for one of our variable cash programs (bonus or commission) and eligible roles may receive equity as part of the compensation package. We offer a wide range of benefits as innovative as our work, including access to genomics sequencing, family planning, health/dental/vision, retirement benefits, and paid time off. We are a company deeply rooted in belonging, promoting an inclusive environment where employees feel valued and empowered to contribute to our mission. Built on a strong foundation, Illumina has always prioritized openness, collaboration, and seeking alternative perspectives to propel innovation in genomics. We are proud to confirm a zero-net gap in pay, regardless of gender, ethnicity, or race. We also have several Employee Resource Groups (ERG) that deliver career development experiences, increase cultural awareness, and offer opportunities to engage in social responsibility. We are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information. Illumina conducts background checks on applicants for whom a conditional offer of employment has been made. Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable local, state, and federal laws. Background check results may potentially result in the withdrawal of a conditional offer of employment. The background check process and any decisions made as a result shall be made in accordance with all applicable local, state, and federal laws. Illumina prohibits the use of generative artificial intelligence (AI) in the application and interview process. If you require accommodation to complete the application or interview process, please contact accommodations@illumina.com. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf. The position will be posted until a final candidate is selected or the requisition has a sufficient number of qualified applicants. This role is not eligible for visa sponsorship.
THE POSITION A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That’s what makes us Roche. The Opportunity We are hiring QC Associate I to join our team, focusing on microbiology testing support. In this role, you will be responsible for: Core Responsibilities: Collect, process, analyze, and report data for samples associated with utilities, environmental monitoring (EM), cleaning validation/verification samples, and product samples. Execute and document routine and non-routine testing to support data generation, including bioburden, endotoxin, TOC, conductivity, and other general techniques according to established procedures. Compliance and Quality System Adherence: Apply advanced knowledge of GMP, GDP, and Data Integrity ALCOA principles daily. Ensuring compliance with GMP requirements through accurate testing, detailed documentation, and timely reporting of all results. Follow established safety and environmental guidelines and maintain the laboratory in an inspection-ready state (e.g.,5S implementation) Equipment Maintenance and Readiness: Maintain laboratory equipment and ensure proper calibration and documentation. Technical Support and Troubleshooting: Perform basic troubleshooting of microbiological and chemical assays and provide initial support for instrument issues to minimize downtime. Materials and Inventory Management: Manage laboratory supplies by performing inventory checks and stocking supplies as needed (e.g., media, reagents). Investigation and Data Review: Assist in data trending and data review for conformance to specifications/limits. Identify and escalate OOS, OAL, or atypical results. Support laboratory investigations, deviations, and CAPAs as needed. Training and Cross-Functional Liaison: Complete required onboarding and ongoing GMP/laboratory training within established timelines. Maintain training compliance and qualifications for all assigned methods and tasks. Assist in training and mentoring others in basics to complex laboratory tasks and troubleshooting techniques, as applicable. Participate in cross-training across microbiology and chemistry testing to support operational flexibility. Serve as a liaison for daily activities and special projects within QC or cross-functionally. Independent Execution: Demonstrate the ability to work independently with little supervision and provide support for the execution of studies and protocols as needed Who you are You possess a Bachelor’s degree in Chemistry, Biochemistry, or a related scientific discipline with 3-4 years of experience in GMP-regulated laboratory. Knowledge, Skills, and Abilities Strong attention to detail and data integrity mindset Good understanding of aseptic techniques and cleanroom practices. Work in office and laboratory environments. May work in the clean room environment that requires gowning and no make up or jewelry May work in the clean room environment where it is loud due to different equipment operating Work in office and laboratory environments GMP Execution & Compliance: Experience working in a GMP environment with the ability to read and follow Standard Operating Procedures (SOP) precisely. Possesses knowledge of laboratory safety procedures and basic experience supporting quality events. Data & Systems Proficiency: Proficiency with laboratory electronic systems, including LIMS and Microsoft Office. Agile Teamwork & Organization: Demonstrates excellent organizational skills and the ability to be agile and work independently in a fast-paced environment. Ability to adapt and work across multiple functional areas (cross-trained environment). Ability to manage multiple tasks and meet timelines. Quality Mindset & Communication: Excellent interpersonal, written, and verbal communication skills. Possesses a continuous improvement mindset and basic experience supporting audit or inspection activities. May be required to work overtime, some evenings and weekends Physical & Work Environment Requirements Must be able to stand, walk, and use laboratory equipment for extended periods. Ability to lift up to 35 lbs and wear necessary personal protective equipment (PPE). Work is performed in a cGMP-regulated manufacturing facility. Work in the laboratory and with instruments that may involve exposure to hazardous chemicals (corrosive, toxic, flammable, etc) Relocation benefits are available for this posting The expected salary range for this position based on the primary location of California is $52,600 - $80,000 Annual. 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 Apr 7th 2026 Job ID 202604-108498
The Position A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That’s what makes us Roche. The Opportunity We are hiring QC Associate I to join our team, focusing on microbiology testing support. In this role, you will be responsible for: Core Responsibilities: Collect, process, analyze, and report data for samples associated with utilities, environmental monitoring (EM), cleaning validation/verification samples, and product samples. Execute and document routine and non-routine testing to support data generation, including bioburden, endotoxin, TOC, conductivity, and other general techniques according to established procedures. Compliance and Quality System Adherence: Apply advanced knowledge of GMP, GDP, and Data Integrity ALCOA principles daily. Ensuring compliance with GMP requirements through accurate testing, detailed documentation, and timely reporting of all results. Follow established safety and environmental guidelines and maintain the laboratory in an inspection-ready state (e.g.,5S implementation) Equipment Maintenance and Readiness: Maintain laboratory equipment and ensure proper calibration and documentation. Technical Support and Troubleshooting: Perform basic troubleshooting of microbiological and chemical assays and provide initial support for instrument issues to minimize downtime. Materials and Inventory Management: Manage laboratory supplies by performing inventory checks and stocking supplies as needed (e.g., media, reagents). Investigation and Data Review: Assist in data trending and data review for conformance to specifications/limits. Identify and escalate OOS, OAL, or atypical results. Support laboratory investigations, deviations, and CAPAs as needed. Training and Cross-Functional Liaison: Complete required onboarding and ongoing GMP/laboratory training within established timelines. Maintain training compliance and qualifications for all assigned methods and tasks. Assist in training and mentoring others in basics to complex laboratory tasks and troubleshooting techniques, as applicable. Participate in cross-training across microbiology and chemistry testing to support operational flexibility. Serve as a liaison for daily activities and special projects within QC or cross-functionally. Independent Execution: Demonstrate the ability to work independently with little supervision and provide support for the execution of studies and protocols as needed Who you are You possess a Bachelor’s degree in Chemistry, Biochemistry, or a related scientific discipline with 3-4 years of experience in GMP-regulated laboratory. Knowledge, Skills, and Abilities Strong attention to detail and data integrity mindset Good understanding of aseptic techniques and cleanroom practices. Work in office and laboratory environments. May work in the clean room environment that requires gowning and no make up or jewelry May work in the clean room environment where it is loud due to different equipment operating Work in office and laboratory environments GMP Execution & Compliance: Experience working in a GMP environment with the ability to read and follow Standard Operating Procedures (SOP) precisely. Possesses knowledge of laboratory safety procedures and basic experience supporting quality events. Data & Systems Proficiency: Proficiency with laboratory electronic systems, including LIMS and Microsoft Office. Agile Teamwork & Organization: Demonstrates excellent organizational skills and the ability to be agile and work independently in a fast-paced environment. Ability to adapt and work across multiple functional areas (cross-trained environment). Ability to manage multiple tasks and meet timelines. Quality Mindset & Communication: Excellent interpersonal, written, and verbal communication skills. Possesses a continuous improvement mindset and basic experience supporting audit or inspection activities. May be required to work overtime, some evenings and weekends Physical & Work Environment Requirements Must be able to stand, walk, and use laboratory equipment for extended periods. Ability to lift up to 35 lbs and wear necessary personal protective equipment (PPE). Work is performed in a cGMP-regulated manufacturing facility. Work in the laboratory and with instruments that may involve exposure to hazardous chemicals (corrosive, toxic, flammable, etc) Relocation benefits are available for this posting The expected salary range for this position based on the primary location of California is $52,600 - $80,000 Annual. 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.