Quality Engineering Manager: NPI, CAPA & Compliance Leader
RXinsider
Thermo Fisher Scientific in California seeks a Quality Engineering Manager to lead the QE team, guiding risk-based decisions across product lifecycles. You will drive CAPA, NC, deviations investigations and ensure NPI quality deliverables are met. Reporting to the Senior Manager, Quality, you will partner with Engineering, Operations, R&D and other functions to ensure compliance with 21 CFR Part 820, ISO 13485, ISO 14971, IVDD/IVDR, and MDSAP, while developing a proactive quality culture. #J-18808-Ljbffr RXinsider
Vacancy posted 4 days ago
Similar jobs that could be interesting for youBased on the Quality Engineering Manager: NPI, CAPA & Compliance Leader in Fremont, CA vacancy
- ...markets, we combine engineering expertise,... ...deliver reliable, high-quality solutions—from product... ...Engineering Manager Location: Newark... ..., quality systems compliance, and continuous improvement... ...Introduction (NPI) activities to... ...Preventive Action (CAPA) programs and...SuggestedFull time
Unigen
Newark, CA4 days ago $105k - $135k
...as a technology leader, Sanmina... ...delivering superior quality and support to... ...comprehensive engineering and test capabilities... ...plant Quality Manager, you will be... ...including NCR and CAPA system,... ...Maintain the site QMS compliance with ISO 9001:2... ...plans) for NPI and production...SuggestedPermanent employmentWork at officeSanmina
Newark, CA10 hours ago- ...Quality Engineer to ensure product quality, reliability, and compliance throughout the product lifecycle. This role... ...maintain the Quality Management System (QMS) aligned... .../preventive actions (CAPA) Support supplier... ...globally recognized leader in GPU-accelerated IT...SuggestedContract workFlexible hours
AMAX
Fremont, CA3 hours ago - ...Supplier Quality Engineer On-SEM-Site Supplier Quality Engineer providing... ...assembly Verify worker compliance with manufacturing... ...SEM Quality Engineers with CAPA reports Oversee SEM RMA process... ...Proficiency with Quality Management System (Ex. ISO-9001, etc.)...Suggested
Advantest
Fremont, CA2 days ago - ...team is passionate about quality craftsmanship.... ...The Quality Assurance Engineer (Manufacturing) supports... ...quality processes that ensure compliance with customer, regulatory... ...document control, risk management, nonconformance management, and CAPA. Conduct internal audits...SuggestedMonday to FridayShift work
South Bay Solutions
Fremont, CA20 days ago - ...headquartered in Fremont, CA, seeks a Quality Manager to lead the Quality Management System and ensure compliance with ISO 9001 and customer... .... You will drive audits, CAPA, supplier qualification, and... ...manufacturing, supply chain, engineering, and service functions. The...
- The New Product Introduction (NPI) Engineering Program Manager coordinates cross-functional efforts to execute NPI projects and ensure successful product... ...deliverables across engineering, manufacturing, and quality functions to ensure timely execution. Lead build...Local area
- Molex is seeking an NPI Program Manager to lead assigned customer programs, align resources across functional teams, and drive execution of commitments and business objectives. You will oversee demand planning, delivery, issue resolution, and continuous improvement with...
$150k - $200k
...as a technology leader, Sanmina... ...delivering superior quality and support to... ...Introduction (NPI), and Design for... ...automation, and complex engineering. Fremont... ...engineering, and account management. Working at... ...environmental compliance standards.... ...preventive actions (CAPA). Team and...Permanent employmentWork experience placementFlexible hoursSanmina
Fremont, CA3 days ago$60k
...our employees. The Specialist, Quality Assurance executes assigned... ...quality activities to ensure full compliance with product requirements,... ...matter experts (SMEs) and management system owners (MSOs) in completing... ...as SOP updates required by CAPA activities Perform data...Local area$100k - $130k
...Technical Recruiter & BD Manager @ IntelliPro... ...and hands-on Quality Engineer to bolster our Manufacturing... ...actions (CAPA) to mitigate quality... ...Product Introduction (NPI) processes and... ...audits and uphold compliance with ISO 9001 and... ...IntelliPro is a global leader in talent...Full timeWork experience placementWork at officeRemote workIntellipro, Inc.
Union City, CA2 days ago$107.07k - $153.91k
...Quality Engineer Department: Quality Employment Type: Full Time Location: Swagelok... ...California Reporting To: Quality Assurance Manager Compensation: $107,070 - $153,913 /... ...Quality Management System, ensuring compliance while reducing process variation,...Full timeTemporary workWork experience placementWork at officeFlexible hoursSwagelok Northern California
Fremont, CA4 days ago$110k - $140k
...for a motivated Senior Quality Engineer who wants to build a... ...introduction of new products (NPI) through sustaining... ...and company SOPs. Manage multiple projects... ...requirements. Support the CAPA program to facilitate... ...review ECOs to ensure compliance to quality system....Permanent employmentWork experience placementSanmina-SCI Systems de México
Fremont, CA4 days ago- ...Quality Engineer Unigen is a global technology company providing... .... Reports to Senior Manager of QE and QA located... ..., or unresolved CAPA issues. Stop the line... ...defect reduction, and compliance. Ensure compliance... ...product introduction (NPI). Maintain Approved...
Unigen
Newark, CA2 days ago $121k - $191k
...The Senior Supplier Quality Engineer drives supplier quality... ...subassemblies. Evaluate compliance to relevant... ...root cause analysis, CAPA, and containment actions... ...Strong knowledge of NPI quality requirements at... ...and risk-based supplier management. Proficiency with analytical...Full timeTemporary workRelocation packageFlexible hoursAgility Robotics
Fremont, CA2 days ago- ...worldwide. Increasing quality, reliability,... ...seeking a Quality Manager. Position Summary... ...(QMS) to ensure compliance with ISO 9001 requirements... ..., supply chain, engineering, and service... ...Preventive Action (CAPA) processes and ensure... ...introduction (NPI) activities by ensuring...Contract workWork at officeWorldwide
Aehr Test
Fremont, CA1 day ago - ...Job Description DESCRIPTION: The Engineering NPI Project Manager is responsible for leading New... ...closely with Engineering, Manufacturing, Quality, Supply Chain, Production Control, Operations... ...launch performance. • Maintain compliance with ISO procedures, customer...Work at office
FM Industries
Fremont, CAa month ago - ...Skydio is seeking an Advanced / NPI Quality Engineer to own product quality from concept through ramp for one product. You’ll set targets, facilitate risk analysis, qualify suppliers and measurement systems, and sign off on gates. The role combines DFMEA leadership...
$145k - $257k
...leading US drone company and the world leader in autonomous flight, the key... ...Role: Skydio is seeking an Advanced / NPI Quality Engineer to own product quality from concept through... ...85. FCC/CE, UN 38.3, or IP ingress compliance exposure. ~ Obtaining FAA Part 107 certification...Full timeLocal areaRelocation package- ...PacificDepartment: Quality / Supplier... ...Supplier Quality Engineer (SQE) to join our... ...conducting Quality Management System and manufacturing... ...nEvaluate supplier compliance with applicable quality... ...Action (CAPA)activities for significant... ...introduction (NPI) and design transfer...Shift work
Pivotal Systems
Fremont, CA14 days ago - Zoetis is seeking a qualified Process Engineer to measure and specify requirements for best-in-class quality products and manufacturing design. The role requires cross... ...qualifications as needed. The candidate will lead CAPA investigations, support manufacturing...
- ...Nextpower LLC in Fremont seeks a visionary VP, Operations Engineering to lead NPI and product industrialization, transforming a portfolio of technologies into a scalable, globally competitive platform. You will own the NPI process from R&D handoff to supply chain readiness...
$175k - $225k
...Summary This Associate Director, Quality Assurance role will be responsible for leading and managing QA activities, oversight, and... ...guidelines to ensure GMP Manufacturing compliance. This position will report to... ...and preventative actions (CAPA), and aligned decision-making...Full timeTemporary workWork at officeFlexible hours- ...JOB SUMMARY The Principal Supplier Quality Engineer is the company’s technical leader and subject matter expert for supplier quality management. This position is responsible for... ...safety, supply continuity, and regulatory compliance. This position is based in the...Contract workWork experience placementWork at office
THINK Surgical, Inc.
Fremont, CAa month ago $40 - $55 per hour
...: We are seeking an experienced Quality Manager to lead and improve our quality management... ...final inspection, while ensuring compliance with customer requirements, engineering drawings, and ISO standards. The... ...and preventive actions (CAPA). Lead non-conforming material control...Hourly pay- Quality - Sr. Quality EngineerJob Responsibilities:Open, investigate... ...MonitoringParticipating in CAPA ProjectsParticipate in validation... ...years in Quality or related engineering roles within manufacturing... ...documentation.Strong time/task management, responsiveness, proactive...Work at office
Viant Medical
Fremont, CA1 day ago $27.35 - $35.56 per hour
...Services (FSS) Program, the Early Childhood Quality Assurance Coordinator provides... ...quality support to the FSS team to ensure compliance with program standards, quality assurance... ...serves as a key support resource to Case Managers by assisting with workflow coordination,...Hourly payFull timeWork at officeMonday to FridayFlexible hours$188k - $230k
...Associate Director, Quality Auditing & Compliance is responsible for leading... ...with functional leaders to ensure timely and... ...of the Quality Management System (QMS). Responsibilities... ...preventive actions (CAPAs) and monitor... ...sciences, pharmacy, engineering, or a related discipline...Full timeWork at officeFlexible hours2 days per week3 days per week$240k - $280k
...Description:The Sr. Director of Quality Control is a member of the Quality and Compliance Leadership Team responsible for... ...provides oversight for sample management, stability, in-process and environmental... ..., Chemistry, Biochemical Engineering, or a related discipline;...Full timeAsahi Kasei
Fremont, CA10 hours ago- Hyundai America Technical Center, Inc. (HATCI) is seeking a Senior Manager of Human Resources to lead the HR team at our Superior,... ...functional partnering with Global HR. The role includes ensuring compliance with U.S. #J-18808-Ljbffr Hyundai America Technical Center,...
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Quality Engineering Manager: NPI, CAPA & Compliance Leader. Be the first to apply!
Related searches
- quality systems engineer Fremont, CA
- senior quality systems engineer Fremont, CA
- senior manager quality engineering Fremont, CA
- program quality engineer Fremont, CA
- customer quality engineer Fremont, CA
- quality assurance quality control engineer Fremont, CA
- senior supplier quality engineer Fremont, CA
- advanced quality engineer Fremont, CA
- quality engineer- qms Fremont, CA
- senior data quality engineer Fremont, CA