170 capa jobs at 101 companies in Mountain View, CA
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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/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.
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)
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
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
Copy of Senior R&D Quality Officer, Product Development Quality Assurance
San Francisco or Irvine
$110k-$209k/yrHybridFull Time
AbbVieNYSE: ABBV: Develops and sells innovative pharmaceutical and biopharmaceutical medicines.
4+ YOEBachelor's degree in a relevant life sciences field; 4–6 years of progressive pharmaceutical QA experience; GMP knowledge; batch record review, TPM oversight, investigations, CAPA, and strong communication skills.
Standard Operating Procedures (SOPs), Electronic batch record, Quality management systems, CAPA, ICH Q7, ICH Q10, 21 CFR Parts 210/211, EU GMP Annexes
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
StandardAeroNYSE: SARO: Provides maintenance, repair, and overhaul services for aircraft engines.
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
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