179 capa jobs at 105 companies in San Francisco, 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
Irvine or Somerset or Piscataway or Titusville or Horsham or West Chester or Bridgewater or Jacksonville or Malvern or Princeton or New Brunswick or Raritan or Milpitas or Limerick
$122k-$213k/yrHybridFull Time
Johnson & JohnsonNYSE: JNJ: Develops and manufactures pharmaceutical drugs and medical devices.
8+ YOEBachelor's degree and 8+ years in a regulated industry required, with cross-functional program leadership, supply chain, risk management, CAPA, root cause analysis, and global team experience.
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%.
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
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.
Limerick or Irvine or New Jersey or Bridgewater or Raritan or Titusville or New Brunswick or Piscataway or Princeton or Somerset or Pennsylvania or West Chester or Horsham or Malvern or Jacksonville or Milpitas
€85k-€146k/yrHybridFull Time
Johnson & JohnsonNYSE: JNJ: Provides pharmaceutical products and medical technology healthcare solutions.
8+ YOEBachelor's degree and 8+ years in medical device, pharmaceutical, healthcare, or regulated industry; requires cross-functional leadership, supply chain, project management, risk mitigation, root cause analysis, and CAPA experience.
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
Sunnyvale or Washington, D.C. or San Diego or Fort Walton Beach or Ann Arbor or London or Stuttgart or Munich or Stockholm or Bengaluru or Seoul or Tokyo
$150k-$200k/yrOnsiteFull Time
Applied Intuition: Developing software and simulation infrastructure for autonomous vehicles.
7+ YOE7+ years in operational compliance, transportation safety, program management, or related work, including 3+ years in a safety-critical or regulated environment; experience owning compliance frameworks, RCA, CAPA, and audit-ready records.
ISO 26262, SOTIF, UL 4600, DOT, FMCSA, OSHA, MSHA, CAPA, RCA
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.
IntuitiveNASDAQ: ISRG: Robotic-assisted systems for minimally invasive surgery.
8+ YOERequires 8+ years in quality engineering or assurance, a bachelor's degree or equivalent, 2+ years in a regulated industry, NPI, electro-mechanical assembly, quality investigations, CAPA, risk management, data analysis, GMP, ISO, and FDA compliance.
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