49 capa jobs at 32 companies in Vacaville, CA
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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
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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.
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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
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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
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
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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
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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
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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
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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
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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
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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
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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
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
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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
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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
1mo
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Senior QMS Specialist
Hayward, California, United States
$147k-$210k/yr OnsiteFull Time
3+ YOE3+ years QA/compliance experience in aerospace/defense, hands-on AS9100D experience, audit support, QMS maintenance, CAPA management, KPI reporting, and cross-functional collaboration.
ERP, MRP, quality management software
3mo
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Quality Control and Continuous Improvement Specialist I
Livermore, California, United States
OnsiteFull Time
Bachelor’s degree in Life Sciences or Engineering; knowledge of CAPA/audits/regulatory compliance; experience with Lean, Six Sigma, 5S, FMEA, and data analysis; strong analytical and teamwork skills.
Lean, Six Sigma, 5S, FMEA, Process Mapping, Statistical Analysis
3w
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Supplier Quality Engineer
Bay Point, California, United States
$84k-$115k/yr OnsiteFull Time
3+ YOEBachelor's in engineering/chemistry,3+ years supplier quality experience,proficiency with ERP/SAP and Microsoft Office,experience with 8D/CAPA and supplier audits,strong communication and problem-solving skills.
ERP, SAP, Microsoft Office
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Senior Quality Specialist
Concord, California, United States
$85k-$95k/yr OnsiteFull Time
6+ YOEB.S. in science desired; 6+ years pharmaceutical/biotech/GMP quality experience; knowledge of ISO 17025:2017, USP, cGMP, FDA, ICH; audit, CAPA, deviation, RCA experience.
1w
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Director of Product Quality & Hard Lines
San Francisco, California, United States
$160k-$185k/yr HybridFull Time
7+ YOE7+ years in product quality, testing, compliance or product development in consumer goods; experience with safety, regulatory compliance, factory audits, supplier management, CAPA, and launching hardware/plastic/technical products.
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