2mo
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Senior Quality Engineer, CAPA (Wayne, NJ) (Wayne, NJ, US)
Wayne, New Jersey, United States
$115k-$130k/yr HybridFull Time
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
1mo
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Quality Control Manager
Perth Amboy, New Jersey, United States
$100k-$115k/yr OnsiteFull Time
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
3w
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Staff Design Quality Engineer
Leesburg or Allendale
$110k-$130k/yr HybridFull Time
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
1mo
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Operations - Quality Engineering Lead
San Francisco or New York City
OnsiteFull Time
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
2mo
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Senior Auditor, Auditing and Due Diligence
Morristown, New Jersey, United States
$135k-$142k/yr HybridFull Time
10+ YOEPlan and execute GxP audits; document findings and CAPA; collaborate with multiple departments; travel 40-50% in North America.
Microsoft Office
2w
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Quality Business Partner - Charlotte, NC.
Charlotte or Burlington
$110k-$118k/yr HybridFull Time
Experience implementing and maintaining QMS and ISO 9001, audit and CAPA management, process improvement, training, SOP creation, and SharePoint/workflow development.
Microsoft SharePoint
4w
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Senior Manager, Clinical Trial Business Delivery
Princeton, New Jersey, United States
$135k-$164k/yr OnsiteFull Time
Oversee clinical study operations, manage CROs/vendors, ensure compliance with regulations and SOPs, monitor trial progress and risks, support audits and CAPAs.
2w
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Quality Assurance Supervisor
Easton, Pennsylvania, United States
OnsiteFull Time
3+ YOE3+ MgmtSupervise QA team, ensure food safety and quality systems, conduct audits, manage CAPA, and support continuous improvement in a food manufacturing environment.
Microsoft Office
2w
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Quality Business Partner - Charlotte, NC.
Charlotte or Burlington
$110k-$118k/yr HybridFull Time
Maintain and improve QMS and ISO compliance, lead audits, manage CAPA, train sites, implement continuous improvement and support quality KPI objectives.
SharePoint
1w
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Quality Manager – Fossil Americas
Atlanta or Toronto or Detroit or Boston or Bangor or New York City or Schenectady
$94k-$156k/yr RemoteFull Time
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%.
PowerNow Platform
3mo
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Quality Manager
Montgomeryville, Pennsylvania, United States
OnsiteFull Time
7+ YOE3+ MgmtExperienced quality leader in defense/aerospace or space programs; AS9100/ISO9001; supplier quality, audits, MRB, CAPA; Six Sigma/Lean; high reliability manufacturing.
ERP/MRP, QMS, SAP, Deltek Costpoint, Microsoft Office, Adobe Acrobat
4w
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Microbiologist (Micro) I, II, & III
Piscataway, New Jersey, United States
$70k-$95k/yr OnsiteFull Time
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.
3w
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Staff Quality Systems Specialist I
Franklin Lakes, New Jersey, United States
$136k-$217k/yr OnsiteFull Time
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.
Trackwise
3w
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TRD QA CGT Modality Head
East Hanover, New Jersey, United States
$176k-$328k/yr OnsiteFull Time
Lead global QA for CGT modalities ensuring GxP compliance, audit and inspection readiness, risk management, deviation and CAPA oversight, people management, and regulatory guidance.
2mo
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Quality Assurance Engineer II
Plainsboro, New Jersey, United States
$71k-$98k/yr OnsiteFull Time
3+ YOEBachelor’s degree in science or engineering; 3-5+ years QA experience in medical device/pharmaceutical manufacturing; strong investigations, root-cause analysis, CAPA, and regulatory knowledge.
MS Office, Statistical software
1mo
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Director, Quality Assurance
East Brunswick, New Jersey, United States
$170k-$200k/yr OnsiteFull Time
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
1mo
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Principal Quality Systems Specialist
Northridge or California or Seattle or Washington or Boston or New York City or Los Angeles County or United States
$121k-$205k/yr OnsiteFull Time
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
1w
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Quality Engineer III
Lansdale, Pennsylvania, United States
OnsiteFull Time
3+ YOEBachelor's in a technical discipline, 3+ years quality engineering experience in supply chain/manufacturing, proficiency with FMEA, SPC, Six Sigma, ISO 9001, root cause analysis and CAPA.
FMEA, SPC, Six Sigma, ISO 9001, ERP, Lean, Kaizen, quality management software
2w
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Validation Engineer II
Branchburg, New Jersey, United States
$75k-$143k/yr OnsiteFull Time
3+ YOEPrepare and execute commissioning/qualification (IQ/OQ/PQ), develop validation documentation, support cleaning validation and CAPA investigations; 3+ years validation/engineering experience preferred; cGMP familiarity.
Kneat, Computer Maintenance Management System (CMMS)
3w
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QA Specialist
East Windsor, New Jersey, United States
$72k-$81k/yr OnsiteFull Time
3+ YOE3+ years GMP experience, strong attention to detail, documentation and SOP authorship, review of deviations/CAPA, proficiency with Microsoft Office and SharePoint/Visio/Oracle, audit support and metrics tracking.
Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Microsoft Outlook, SharePoint, Visio, Oracle
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