Foster City or Thousand Oaks or El Segundo or Santa Monica or Parsippany
$136k-$176k/yrHybridFull Time
Kite PharmaNASDAQ: GILD: Developing engineered cell therapies to treat and cure cancer.
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.
AbbottNYSE: ABT: Provides medical devices, diagnostics, and science-based nutritional products.
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.
Unigen: Manufactures custom memory, storage, and AI electronic hardware solutions.
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.
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
SupermicroNASDAQ: SMCI: Designs and manufactures high-performance server and storage solutions.
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.
Senior Quality Assurance Manager - Surgical Support & Post Market
San Jose, California, United States
$176k-$294k/yrHybridFull Time
StrykerNYSE: SYK: Manufactures medical devices and equipment for healthcare providers.
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
Aehr Test SystemsNASDAQ: AEHR: Provider of semiconductor test and burn-in systems.
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)
SPAN: Sells smart electrical panels for residential energy management.
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%.
Atoms: Building robotics and software to automate physical world industries.
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.
PenumbraNYSE: PEN: Designs and manufactures medical devices for vascular conditions.
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
SMC Ltd.: Global contract manufacturer of medical devices and pharmaceutical products.
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
BioMarinNASDAQ: BMRN: Develops and commercializes therapies for rare genetic diseases.
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.
eCMMS: Provides electronics packaging and reverse logistics for major manufacturers.
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.
Mainspring Energy: Manufactures fuel-flexible linear generators for onsite power generation.
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.
Pivotal Systems: Provides gas flow control technology for semiconductor manufacturing.
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.
Bedrock Robotics: Automates heavy construction machinery with AI retrofit kits.
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
OracleNYSE: ORCL: Provides cloud infrastructure and enterprise software for global businesses.
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