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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.
4w
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Senior Engineer, Quality Systems
San Jose, California, United States
$105k-$141k/yr OnsiteFull Time
5+ YOEBachelor's in engineering/life sciences/quality/regulatory; 5+ years in quality systems or related field; QMS/ISO 13485/21 CFR Part 820 knowledge; audit, CAPA, change control, risk management, technical writing, and stakeholder leadership skills.
2w
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Sr. Quality Systems & Compliance Engineer
San Jose, California, United States
$137k-$189k/yr OnsiteFull Time
6+ YOEBachelor's in engineering/life sciences, 6+ years QMS/quality engineering experience in medical devices, internal/external audit experience, knowledge of ISO 13485 and risk management, eQMS experience, strong problem-solving and communication.
eQMS, Arena
2mo
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Quality & Reliability Systems Engineer - (E3)
Santa Clara, California, United States
$111k-$152k/yr OnsiteFull Time
Develop and maintain quality and reliability standards; perform testing, failure analysis, and reliability modeling; coordinate with suppliers and engineers.
2mo
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Quality & Reliability Systems Engineer - (E3)
Santa Clara, California, United States
$111k-$152k/yr OnsiteFull Time
Entry-level quality and reliability engineer to develop standards and test plans, perform FMECA and failure analysis, reliability modeling, and document testing. Travel ~20% and relocation eligible.
FMECA, CRAMS, PQP, ERAMS
2mo
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Systems Quality and Reliability Engineer - LPU
Santa Clara, California, United States
$136k-$265k/yr HybridFull Time
5+ YOEBS/MS in EE, Physics or related; 5+ yrs systems test/validation; hands-on quality and reliability experience; lab hardware skills; FA techniques/tools knowledge; Python/Perl/C/C++ on UNIX/Linux; PCB/system test and CM coordination.
Oscilloscopes, Logic analyzers, Power analyzers, FIB, SEM, TDR, VNA, CSAM, OBIRCH, DLS/LADA, LVP, LVI, SerDes, PCIe, DDR, Python, Perl, C++, UNIX/Linux
1mo
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Stability Quality Engineer - Data Center Systems Quality
Sunnyvale, California, United States
OnsiteFull Time
Design and execute hardware-centric software tests for system-level stability and stress validation of data center platforms; partner with engineering to uncover risk and influence design decisions.
1w
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Quality Engineer - Metrology
San Carlos, California, United States
$83k-$147k/yr OnsiteFull Time
2+ YOEBachelor's in engineering, 2+ years in quality/metrology, experience with inspection systems, Polyworks/Hexagon tools, CAD, ASME Y14.5, and measurement system analysis.
Polyworks, Hexagon, Laser Tracker, Portable Arm, Coordinate Measuring Machine, CAD, Catia V5, Catia V6, ASME Y 14.5M-2018, GD&T
2mo
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Product Quality Engineer
San Jose, California, United States
$150k-$225k/yr OnsiteFull Time
5+ YOE5+ years in quality engineering for datacenter hardware, servers, or semiconductor systems; experience with overseas/US contract manufacturers; on-site factory work; implement inspection and test processes; ensure quality gates and APQA.
SPC, FMEA, DOE, 8D, CAPA, ISO/AS, IPC
2w
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Product Quality Engineer - Robot
Santa Cruz, California, United States
OnsiteFull Time
5+ YOEBachelor's in engineering, 5+ years medical device quality engineering experience for electromechanical capital devices, knowledge of FDA QSR/ISO 13485/IEC 60601-1, CAPA/NCR investigations, process validation (IQ/OQ/PQ), and quality systems.
FDA QSR, ISO 13485, IEC 60601-1, IQ/OQ/PQ, Six Sigma
4w
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Supplier Quality Engineer II
Santa Clara, California, United States
$170k-$171k/yr OnsiteFull Time
3+ YOEBachelor's in engineering plus 3 years supplier quality experience in medical device industry; experience with quality systems, Minitab, SOLIDWORKS, Six Sigma/Lean, process validation, FMEA, CAPA, and metrology.
Minitab, SOLIDWORKS, MicroVu, Calipers, Go/No-Go Gages
1w
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Director, Quality Systems
San Jose, California, United States
$179k-$251k/yr OnsiteFull Time
12+ YOE3+ Mgmt12+ years quality experience in regulated, high-volume manufacturing with 3+ years management; deep ISO 9001 and IATF 16949 QMS expertise; lean, CAPA, internal audit, CRB/MRB, and strong cross-functional communication.
PLM-Vault, 8D, FMEA, SPC, MSA, APQP, PPAP, IQC, control plans
1mo
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Supplier Quality Engineer
Fremont, California, United States
OnsiteFull Time
6+ YOEBachelor's preferred; minimum 6 years product quality control in manufacturing; proficiency with quality management systems (ISO 9001); root cause analysis; continuous improvement tools; IPC-A-610 CIS.
ISO 9001, IPC-A-610
2w
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Senior Supplier Quality Engineer
Austin or Mountain View or Redmond or Hillsboro or Raleigh
$120k-$235k/yr HybridFull Time
5+ YOEAdvanced degree or equivalent with 5+ years engineering experience in manufacturing/supplier quality for semiconductors; experience with SoC qualification, risk mitigation, audits, and quality systems.
4w
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Supplier Quality Engineer II
Santa Clara, California, United States
$170k-$171k/yr OnsiteFull Time
3+ YOEBachelor's in engineering and 3 years supplier quality experience in medical devices; experience with quality systems (cGMP, FDA 820, ISO 13485), Minitab, SOLIDWORKS, Six Sigma/Lean, process validation, FMEA, CAPA, GD&T, metrology and inspection tools; Lean Six Sigma Green Belt and SOLIDWORKS 2019 training required.
Minitab, SOLIDWORKS, MicroVu
2mo
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Staff Quality Compliance Engineer
San Jose, California, United States
$144k-$170k/yr OnsiteFull Time
8+ YOEBachelor's in a technical field, 8+ years in medical device industry with 5+ years in quality systems/engineering, knowledge of FDA QSR, ISO 13485, EU MDR, computer software validation, CAPA leadership, strong communication and analytical skills.
1mo
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Senior Quality Engineer (On site)
Santa Clara, California, United States
OnsiteFull Time
5+ YOEEngineering bachelor's plus 5+ years relevant experience; expertise in FDA Medical Device Quality System Regulation, MDR, MDSAP, and ISO 13485; QMS, CAPA, audits, and root cause investigation experience.
FDA Medical Device Quality System Regulation, MDR, MDSAP, ISO 13485, Distributed Product Risk Assessments (DPRA)
1w
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Staff Quality System Engineer
Sunnyvale, California, United States
$183k-$263k/yr OnsiteFull Time
12+ YOE12+ years in compliance/quality systems or equivalent, bachelor’s required, global regulatory expertise, audit and remediation leadership, executive communication, program management, and travel availability.
3d
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Hardware Quality Engineer
San Jose, California, United States
$109k-$145k/yr HybridFull Time
Experience with hardware or data center systems, root cause analysis, data analysis and metrics, QMS/quality tools, cross-team collaboration, and willingness to travel up to 30%.
Quality Management Systems (QMS), ERP, Python, SQL
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