80 capa jobs at 54 companies in Fairfield, CA
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Manager, R&D Quality Audits, Inspections and CAPA
Foster City or Thousand Oaks or El Segundo or Santa Monica or Parsippany
$136k-$176k/yr HybridFull Time
4+ YOERequires PharmD/PhD with relevant experience, master's/MBA plus 4+ years, or bachelor's plus 6+ years in quality and compliance. Strong GCP/GVP auditing, CAPA, inspection readiness, analytical, communication, and project skills.
Microsoft Office
2mo
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Sr. Quality Systems/CAPA Engineer
Pleasanton, California, United States
$90k-$180k/yr OnsiteFull Time
5+ YOEBachelor’s in engineering; 5+ years engineering experience; knowledge of FDA 21 CFR 820, ISO 13485, ISO 14971; quality tools; CAPA and audits.
Quality tools, Statistical analysis, CAPA
2mo
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Sr. Quality Systems/CAPA Engineer
Pleasanton, California, United States
$90k-$180k/yr OnsiteFull Time
5+ YOEBachelor’s degree in engineering; 5+ years in engineering with quality tools; knowledge of FDA 21 CFR 820, ISO 13485; CAPA/quality systems experience.
2mo
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Supervisor, Commercial Manufacturing - Day Shift
Sacramento, California, United States
$70k-$100k/yr OnsiteFull Time
2+ MgmtBS in biology required, 2+ years supervisory experience, strong aseptic/cleanroom knowledge, ability to enforce cGMP and SOPs, and support CAPA/deviation investigations.
cGMP, SOPs, CAPA, QA, QC, Biosafety safety cabinets
2mo
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Manufacturing Process Engineer
Santa Rosa, California, United States
$99k-$183k/yr OnsiteFull Time
5+ YOE5+ years manufacturing engineering; degree in chemical/related field; PFMEA/CAPA/8D/SPC knowledge; ITAR clearance eligible; fluent in English; color vision required.
PVD, High Vacuum, MS Office, Excel, PFMEA, CAPA, 8D, SPC
2mo
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Quality Manager
Fremont, California, United States
$120k-$180k/yr OnsiteFull Time
7+ YOE7+ years quality management in high-tech manufacturing; experience with ISO 9001, QMS, audits, CAPA, supplier and manufacturing quality; bachelor\u0002s degree in engineering or related field required.
ISO 9001, SPC, FMEA, Control Plans, CAPA, ERP, Quality Management System (QMS)
1w
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Product Quality Engineer
San Francisco, California, United States
$120k-$156k/yr HybridFull Time
6+ YOEBachelor's in engineering,6+ years in product/field/manufacturing quality,expertise in PCBA, failure analysis, 8D/CAPA/FMEA,data-driven quality metrics,ability to travel up to 50%.
PCBA, DFx, 8D, CAPA, FMEA, Agile PLM, Netsuite ERP
2w
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Head of Quality
San Francisco, California, United States
$170k-$220k/yr OnsiteFull Time
10+ YOE10+ years quality leadership in complex hardware, experience scaling from low-volume to serial production, deep knowledge of IPC, APQP/PPAP, 8D/CAPA/PFMEA, and supplier quality management.
IPC standards, APQP, PPAP, 8D, CAPA, PFMEA
1mo
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Senior Quality Engineer - Metals
Alameda, California, United States
$125k-$175k/yr OnsiteFull Time
5+ YOEBachelor's in engineering, 5+ years quality/manufacturing engineering in medical devices, knowledge of FDA QSR and ISO 13485, strong data analysis and problem-solving, experience with pFMEA, NCR/MRB/CAPA processes.
5 Why, Fishbone Diagram, Design of Experiments (DOE), regression analysis, pFMEA, Measurement System Analysis (MSA), FDA QSR, ISO 13485, NCR, MRB, CAPA
2mo
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Supplier Quality Engineer
Santa Rosa, California, United States
$86k-$103k/yr OnsiteFull Time
2+ YOEBachelor's degree in Engineering; 2-4 years supplier quality in medical device industry; ISO 13485:2016 and 21 CFR 820 knowledge; CAPA/PPAP, audits; Minitab and MS Office; English proficiency.
Minitab, IQMS, Excel, Word, PowerPoint, Outlook, DoE, FMEA, PPAP, CAPA, ISO 13485, Gage R&R, CpK/PpK, DQ/validation (IQ/OQ/PQ), MS Office Suite
1mo
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GEO Supply Chain Operations Associate
Ireland or Novato
OnsiteFull Time, Temporary
3+ YOE3+ years in operations, supply chain, or quality; BS/BA in life sciences, business, or supply chain; experience with ERP, inventory planning/reconciliation, PO/invoice/shipment management; CAPA/FMEA/RCA and GxP knowledge.
ERP, CAPA, FMEA, RCA
1mo
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Quality Analyst, Senior
Stockton, California, United States
$81k-$90k/yr OnsiteFull Time
3+ YOEBachelor's in quality/engineering/manufacturing/industrial technology (or equivalent experience), 3+ years QA experience, 3+ years conducting root cause and CAPA, QMS experience, ability to lift 25 lbs and remain stationary for inspections.
5 Whys, Fishbone, FMEA, Corrective and Preventive Actions (CAPA), Quality Management Systems (QMS), ISO 9001, AS9100, AS9110, FAA regulations, Lean Manufacturing, Six Sigma
2w
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Supply Chain Quality Engineer
Fremont, California, United States
OnsiteFull Time
3+ YOEBachelor's in engineering or related field, 3+ years supplier quality or incoming inspection experience, supplier audits, 8D/CAPA, FMEA, SPC, ANSI/ASQ Z1.4, first article inspection, hands-on measurement and drawing interpretation, willingness to travel internationally.
8D, CAPA, FMEA, SPC, ANSI/ASQ Z1.4, MRB
1mo
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Operations - Quality Engineering Lead
San Francisco or New York City
OnsiteFull Time
8+ YOE8+ years in quality program or product quality roles; experience across NPI and manufacturing quality; deep knowledge of FMEA, SPC, CAPA, 8D, Six Sigma; strong cross-functional leadership and problem-solving skills; experience with robotics or hardware preferred.
FMEA, SPC, CAPA, 8D, Six Sigma, HIL, SIL, HALT, HASS, AI agents and tools
1mo
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Quality Assurance Engineer III
Concord, California, United States
$121k-$148k/yr OnsiteFull Time
5+ YOEBachelor's in engineering or science; 5+ years QA/systems experience supporting manufacturing (medical device experience preferred); experience with IEC 62304/SDLC, risk analysis, testing, CAPA, audits, supplier quality, and quality tools (FMEA, DOE, Six Sigma); ~10% travel.
Software Development Life Cycle (SDLC), IEC 62304, Smartsheet, Veeva, FMEA, DOE, Six Sigma, CAPA
1mo
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Senior Fabrication Quality Manager
Fremont, California, United States
$130k-$190k/yr OnsiteFull Time
6+ YOE6+ MgmtBachelor's degree, 6+ years quality engineering experience in manufacturing with leadership, hands-on knowledge of FMEA, control plans, CAPA, RCCA, 8D, internal audit, Lean/Six Sigma, SPC/DOE, IPC preferred, Microsoft Office and Google Docs proficiency, US citizen or LPR required for ITAR facility.
FMEA, PFMEA, CAPA, RCCA, 8D, Design of Experiments, Statistical Process Control (SPC), IPC, Microsoft Office, Google Docs
3w
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LMS & QMS Compliance Administrator
Santa Rosa, California, United States
$30-$40/hr OnsiteFull Time
2+ YOE2+ years in quality systems (CAPA/complaints) preferred, high school diploma required, knowledge of ISO 13485 and 21 CFR Part 820, internal auditing and CAPA skills, strong communication and computer skills.
Microsoft Word, Microsoft Excel, Microsoft PowerPoint
2mo
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QMS Compliance Manager - IVD cGMP
Fremont, California, United States
$131k-$165k/yr OnsiteFull Time
8+ YOELead QMS development and compliance for IVD cGMP across FDA/ISO regimes; audit, CAPA, training; cross-functional leadership.
2mo
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Senior Staff Quality Engineer, Manufacturing
Alameda, California, United States
$156k-$197k/yr OnsiteFull Time
10+ YOE10+ years in quality engineering in ISO 9001/IATF 16949/AS9100 or GMP; strong RCA, CAPA, SPC/SQC; cross-functional leadership; mentoring.
8D, 5 Whys, FMEA, SPC, SQC
2w
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Clinical Nurse Educator III, Perioperative RN
Sacramento, California, United States
$91-$127/hr OnsiteFull Time
5+ YOEActive California RN, BLS required, CNOR/CPAN/CAPA preferred, BSN/MSN preferred, 5 years relevant experience, EHR and teaching skills required.
Microsoft Word, Microsoft PowerPoint, Publisher, Microsoft Outlook, Microsoft SharePoint, Adobe Captivate, HealthStream, Epic
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