132 capa jobs at 75 companies in Tracy, CA
1d
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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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Senior Manager, Quality Operations
Redwood City, California, United States
$175k-$190k/yr OnsiteFull Time
Senior-level GMP QA leader with experience in QA operations, QMS, document control, deviations, change control, CAPA, batch review, and supplier qualification.
Quality Management System (QMS), CAPA, batch record review, document control, training, Aseptic technique
3mo
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Quality Engineer
Newark, California, United States
$75k-$95k/yr OnsiteFull Time
2+ YOEMinimum BS in Engineering; 2+ years in Quality Engineering/QA; knowledge of ISO 9001, AS9100, FMEA, RCCA, 8D, CAPA; strong analytical and communication skills.
SPC, MSA, FMEA, CAPA, CofC, FAI
3d
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Production Quality Engineer
San Jose, California, United States
$75k-$138k/yr OnsiteFull Time
4+ YOEBS in EE/IE required, 4+ years in electronic/computer product quality, supplier quality and CAPA experience, DOE and failure analysis, strong communication and problem-solving.
Microsoft Excel, 8D, 5-Why, Fishbone, FMEA, CAPA
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)
3d
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Senior Quality Assurance Manager - Surgical Support & Post Market
San Jose, California, United States
$176k-$294k/yr HybridFull Time
10+ YOE4+ MgmtBachelor's in engineering or science, 10+ years in regulated manufacturing, 4+ years people leadership, quality and risk tool experience (RCA, FMEA, SPC, CAPA), regulatory compliance (FDA) experience.
Root Cause Analysis, FMEA, Statistical Process Control (SPC), CAPA, Six Sigma
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
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
1w
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QP Engineer
Santa Clara, California, United States
$120k-$140k/yr OnsiteFull Time
4+ YOEManage quality programs, document control, customer quality service, and QMS for AI server/rack manufacturing; 4+ years quality experience; Bachelor\u0002s in engineering or related; ISO 9001 and auditing knowledge; 8D/CAPA experience.
8D, CAPA
1mo
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Staff Reliability Engineer, Electrical Systems
Menlo Park, California, United States
$151k-$178k/yr OnsiteFull Time
8+ YOEBS in EE or ME; 8+ years testing mechanical/electromechanical/electrical systems (or 5+ with MS); experience with FMEA, HALT, failure analysis, CAPA/RCA/8D; data analysis using Python/MATLAB/JMP/Weibull++ and DAQ instrumentation.
FMEA, HALT, Python, MATLAB, Google Docs, Weibull ++, JMP, DAQ, CAPA, RCA, 8D, UL, NFPA, IEC, X-ray, CT, optical microscopy
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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Principal Supply Chain Quality Engineer
Santa Clara or United States
$102k-$210k/yr OnsiteFull Time
10+ YOE10+ years in manufacturing or supplier quality engineering within electronics/hardware/semiconductor environments; bachelor's in engineering or related field required; expert in SPC, DOE, FMEA, MSA, CAPA, QMS; Lean/Six Sigma experience; supplier quality and NPI leadership.
Statistical Process Control (SPC), Design of Experiments (DOE), Failure Mode and Effects Analysis (FMEA), Measurement Systems Analysis (MSA), Process Capability Analysis, PFMEAs, CAPA Systems, Quality Management Systems (QMS), Advanced Statistical Analysis, Lean, Six Sigma
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
2mo
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Global Product Support (GPS) Engineer II – (E2)
Santa Clara, California, United States
$100k-$137k/yr OnsiteFull Time
Product support, troubleshooting, documentation, process improvement, CAPA, FMECA, and customer training.
Microsoft Office, Oscilloscope, Multimeter, Electrical schematics
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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Quality Engineer 1
Mountain View, California, United States
$47/hr OnsitePart Time
3+ YOEAerospace quality experience 3-5 years; AS9100/AS9102; ability to read blueprints; root cause and CAPA; audits; US citizen.
MS Office, Blueprint reading
2mo
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Sr Manager Manufacturing Engineering, Bioproduction (Onsite)
Santa Clara, California, United States
$156k-$207k/yr OnsiteFull Time
10+ YOE6+ MgmtExtensive manufacturing engineering experience with leadership; GMP/FDA/ISO knowledge; NPI & CAPA; lean methods; DOE/FEA experience preferred.
DOE, FMEA, FEA, SPC
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