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
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.
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
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.
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
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.
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
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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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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Supervisor, Quality Assurance
Piscataway, New Jersey, United States
OnsiteFull Time
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.
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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Quality Control Specialist (Weekend) (5551)
Cranbury, New Jersey, United States
$60k-$96k/yr OnsiteFull Time
1+ YOEPerform GMP sampling and QC testing of environmental, water, gas, and raw material samples; document results, investigate OOS/OOL, support CAPA and validation; proficiency with lab software and English.
TOC, Empower, TrackWise, Master Control, LES, LIMS, lab notebook
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
1mo
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Quality Manager
Fairfield, New Jersey, United States
$100k-$110k/yr OnsiteFull Time
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.
Microsoft Office
1w
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Manager, Site Quality Head (2026-8006)
Lakewood, New Jersey, United States
$100k-$130k/yr OnsiteFull Time
4+ YOE4+ MgmtBachelor's in engineering/life sciences or 10+ years related experience; 4+ years GxP leadership; expertise in cGMP/GDP, internal and client/regulatory audits, CAPA, and cross-functional process improvement.
2mo
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QA Product Manager (Sterile Products) - Contractor
Florham Park, New Jersey, United States
$65-$85/hr HybridContract
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.
Veeva, MS Word, MS Excel, Outlook
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