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.
MiniMed GroupNasdaq: MMED: A focused on developing insulin delivery systems and connected diabetes care to improve daily life for people with diabetes.
5+ YOEBachelor's degree with 7+ years (or advanced degree with 5+ years) in medical device/pharma quality, 3+ years CAPA experience, audit support, regulatory knowledge, and CAPA system experience.
Applied Medical: Manufacturer of advanced medical devices and surgical products.
Bachelor's in Engineering/STEM required (or related experience). Strong problem solving, root cause analysis, statistics, and communication. Working knowledge of Microsoft Office; ETQ Reliance experience preferred.
Microsoft Office, Microsoft Word, Microsoft Excel, Microsoft Outlook, ETQ Reliance
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.
General Atomics: Designs and manufactures unmanned aircraft and nuclear technology systems.
4+ YOEBachelor's or master's in engineering with 4–6+ years engineering experience, ability to obtain DoD Secret clearance, leadership, root cause analysis, PFMEA, SAP experience, strong communication and project management skills.
Mach Industries: Designs and manufactures autonomous unmanned aerial vehicles for defense.
5+ YOEBachelor’s in Engineering/Manufacturing/Quality; 5+ years in quality management in aerospace/defense; AS9100 knowledge; audit and CAPA; strong leadership.
AS9100, Quality Management System (QMS), CAPA, Nonconformance Reporting (NCR)
Orca Bio: High-precision cell therapies for blood cancers and autoimmune diseases.
2+ MgmtBS in biology required, 2+ years supervisory experience, strong aseptic/cleanroom knowledge, ability to enforce cGMP and SOPs, and support CAPA/deviation investigations.
Space Kinetic: Developing propellant-free systems for deploying payloads in space.
3+ YOEBachelor's in Engineering, 3+ years in aerospace or regulated manufacturing, working knowledge of AS9100D/AS9102, inspection methods, GD&T, CAPA, and root cause analysis.
AS9100D, AS9102, GD&T, CAPA, NIST SP 800-171, CMMC, ITAR, ERP, QMS, electronic document control systems
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.
Quantic Electronics: Manufacturer of mission-critical electronic components and systems.
5+ YOEBachelor's in engineering/quality or related; 5+ years in quality leadership in manufacturing; experience with ISO 9001, audits, 8D/CAPA/FMEA/SPC; quality certifications preferred.
ISO 9001, 8D, CAPA, FMEA, SPC, IPC Standards, Microsoft Office
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.
Karman Industries: Modular electric heat pumps for industrial thermal energy management.
5+ YOE5+ years in quality engineering; hands-on QMS ownership; working knowledge of ISO 9001 and audit process; experience with CAPA, RCA, and structured problem solving; ability to work autonomously.
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