GetingeNasdaq Stockholm: GETI B: Manufactures medical equipment for acute care and life sciences.
5+ YOEBachelor's in engineering or science required, 5+ years managing CAPA processes, proficiency with TrackWise, Minitab and Microsoft Office, knowledge of ISO 13485 and FDA 21 CFR Part 820, strong root-cause analysis and auditing skills.
TrackWise, Minitab, Microsoft Word, Microsoft Excel, Microsoft PowerPoint
Englert: Manufacturer of metal roofing and seamless gutter systems.
5+ YOEDevelop and lead quality strategy, manage quality team, maintain QMS, oversee inspections, analyze defects and drive CAPA, and lead continuous improvement in manufacturing.
QMS, ISO 9001, SPC, Lean, Six Sigma, FMEA, CAPA, CMM
VB Spine: A medical device focused on supporting surgeons and ensuring design and product quality throughout the product lifecycle.
4+ YOEBachelors in science/engineering required, 4+ years in medical device or regulated industries, experience with design controls, risk management, V&V, CAPA, and quality tools; MS/CQE/CRE and Six Sigma preferred.
FMEA, GD&T, Root Cause Analysis, Minitab, Microsoft Office, CAD, CAPA, Mistake Proofing
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
Greenfield Global: Produces high-purity alcohols, specialty solvents, and sustainable biofuels.
7+ YOEBachelor's degree, 7+ years in quality or supplier quality within a GMP/ISO regulated environment; working knowledge of ISO 9001, IPEC-PQG GMP, EXCiPACT; experience with supplier audits, supplier development, QMS, SCAR/CAPA, and risk-based supplier quality.
ISO 9001, IPEC-PQG GMP, EXCiPACT, QMS, SCAR, CAPA, Management of Change (MoC)
Atlanta or Toronto or Detroit or Boston or Bangor or New York City or Schenectady
$94k-$156k/yrRemoteFull Time
GE VernovaNYSE: GEV: Designs and services technologies for global power generation and electrification.
Bachelor's in engineering or related, proven quality experience in manufacturing/field service, expertise in nonconformance, RCA/CAPA and continuous improvement, willingness to travel ~10–30%.
Kashiv BioSciences: Develops biosimilars and drug delivery systems for medicine improvement.
0+ YOEBachelor's in science/engineering, 0+ to 5+ years microbiology experience in cGMP biologics/biosimilars manufacturing (level-dependent). Knowledge of cGMP, deviation/CAPA, validation desired.
BDNYSE: BDX: Manufactures medical devices, surgical instruments, and pharmacy automation systems.
8+ YOEBS in engineering or science,8+ years medical device/biologic/pharmaceutical/diagnostic experience,knowledge of 21CFR820,ISO13485,MDR/MDD,MDSAP,audit and CAPA expertise.
NovartisNew York Stock Exchange: NVS: Develops and manufactures innovative prescription medicines for patients.
Lead global QA for CGT modalities ensuring GxP compliance, audit and inspection readiness, risk management, deviation and CAPA oversight, people management, and regulatory guidance.
Avet Pharmaceuticals: Manufactures and distributes generic and specialty pharmaceutical products.
10+ YOEBachelor's in a scientific discipline; 10+ years QA leadership in cGMP-regulated pharmaceutical manufacturing (OSD) with inspection, validation, CAPA, and supplier oversight; proficiency with eQMS and Microsoft Office.
Electronic Quality Management Systems (eQMS), Microsoft Office Suite
Northridge or California or Seattle or Washington or Boston or New York City or Los Angeles County or United States
$121k-$205k/yrOnsiteFull Time
MiniMed GroupNasdaq: MMED: A medical device developing insulin delivery systems and connected care solutions for people living with diabetes.
5+ YOEBaccalaureate degree with 7+ years (or advanced degree with 5+ years) in quality systems; experience with QMS, Change Management, CAPA, audits, and Microsoft Office; strong communication and prioritization skills.
Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Agile, Trackwise, Microsoft Teams, Microsoft Project, Power BI
UE Systems: Provides ultrasonic instruments, software and training for predictive maintenance and condition monitoring to prevent downtime, reduce costs and save energy.
8+ YOE8+ years in quality/repair/ supplier or manufacturing quality; experience building QA/QMS, ISO 9001 knowledge, leading NCR/MRB/CAPA, supplier quality, and team leadership.
Amneal PharmaceuticalsNASDAQ: AMRX: Develops and manufactures generic and specialty pharmaceutical products.
1+ YOE1+ MgmtSupervisory QA role requiring pharmaceutical/manufacturing experience (1+ years with BA/BS or more for other credentials) and knowledge of cGMP; responsible for CAPA, audits, SOPs, and batch record oversight.
ShionogiTokyo Stock Exchange: 4507: Research-driven pharmaceutical developing innovative treatments for medical needs.
4+ YOEMinimum 4 years QA experience in sterile drug product manufacturing/oversight; CMOs; batch review; CAPA; regulatory knowledge; QA with external partners; 50% on-site in Florham Park, NJ.
Cartridge Actuated Devices: Manufacturer of high-precision explosive devices and pyrotechnic components.
5+ YOEBachelor's in engineering (or equivalent) and 5+ years post-degree quality engineering experience; familiarity with ISO9000; ability to administer QMS, audits, CAPA, supplier quality; must pass ATF background check.
Legend BiotechNASDAQ: LEGN: Develops cell therapies for the treatment of cancer.
12+ YOEBachelor's in scientific/technical discipline required; 12+ years GxP quality/compliance experience with 5+ years leadership; experience with audits/inspections, CAPA, change control, global GxP regulations, and Microsoft Office.
Microsoft Outlook, Microsoft Excel, Microsoft Word, Microsoft PowerPoint
Baldor Specialty Foods: Distributor of fresh produce and specialty food products.
5+ YOEBachelor's in related field or equivalent, 5+ years in food safety/quality/compliance, PCQI and HACCP, experience with certification programs (SQF, AIB GMP), audit/CAPA leadership, strong analytical and communication skills.
Microsoft Outlook, Microsoft Teams, Microsoft Excel, Microsoft PowerPoint, Microsoft Word, SafeFood360, HighJump
CooperSurgicalNasdaq: COO: Manufactures medical devices for fertility and women's health.
10+ YOELead supplier quality strategy and governance in regulated medical device environments; expertise in FDA QSR, ISO 13485, EU MDR, ISO 14971, audits, CAPA/SCAR, RCA/FMEA, and supplier development.
Microsoft Office, Minitab, ERP systems, eQMS platforms
Contract Pharmacal Corp: Manufactures and packages pharmaceuticals, OTC drugs, and dietary supplements.
Provide technical leadership of quality systems, lead investigations (deviations, complaints, OOS), author protocols and CAPAs, ensure cGMP/FDA/EMA compliance, apply problem-solving methodologies, and support inspection readiness.