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
2mo
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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
2d
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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
1mo
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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)
4w
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Quality Compliance Manager
Hollister, California, United States
OnsiteFull Time
10+ YOE5+ MgmtLeads quality compliance activities, manages audits (AS9100D/ISO9001), oversees corrective actions (CAPA), develops KPIs and training, requires US citizenship and ~10 years quality experience with managerial leadership.
AS9100D, ISO9001:2015, CAPA, Lean, Artificial Intelligence (AI)
1w
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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
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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Senior Quality Engineer
Pleasanton, California, United States
$133k-$180k/yr OnsiteFull Time
7+ YOEBachelor's or Master's in a relevant science/engineering field, 7 years supplier quality engineering in life sciences, experience with supplier audits, CAPA/SCARs, GD&T (ASME Y14.5), and ISO 9001/ISO 13485/FDA/GMP.
GD&T (ASME Y14.5 1994, 2009, & 2018), ISO 9001, ISO 13485, FDA/GMP, CAPA, SCARs
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
1w
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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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Senior Manager/Associate Director, Quality
Palo Alto, California, United States
$180k-$215k/yr OnsiteFull Time
7+ YOE3+ MgmtBachelor's in life sciences/biotech/engineering, 7+ years in quality with 3+ years leadership in biotech/diagnostics; experience with design control, DHF, supplier/CDMO quality, QMS, CAPA, change control, risk management (FMEA); strong cross-functional leadership.
Quality Management System (QMS), Design History File (DHF), SOPs, CAPA, CoAs, SCARs, FMEA, ISO 13485, FDA 21 CFR Part 820 (QSR/QMSR), GMP, CE IVD, UL
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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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
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
3mo
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Production Manager
Bay Point, California, United States
$104k-$155k/yr OnsiteFull Time
2+ YOE2+ MgmtManage paste production, lead SHE, audits, CAPA, budgets, cross-functional collaboration, and continuous improvement.
Excel, Minitab, SAP
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