97 capa jobs at 56 companies in New Rochelle, NY
2d
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Senior Global CAPA Engineer
Trumbull or Livingston
$100k-$125k/yr OnsiteFull Time
5+ YOEBachelor's degree in biomedical engineering or related technical discipline; 5+ years in regulated industries, 3+ years in CAPA or quality experience, regulatory knowledge, and complex investigation experience.
Microsoft Office, Microsoft Word, Microsoft Excel, Microsoft PowerPoint
2w
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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/yr HybridFull Time
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.
Microsoft Office
4w
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QA Sr. Specialist - CAPA
Shirley, New York, United States
$80k-$95k/yr OnsiteFull Time
5+ YOEBachelor's in science/engineering,5+ years QA experience in regulated environment,knowledge of FDA regulations,CAPA writing and risk management,strong analytical and organizational skills.
Microsoft Word, Microsoft Excel, Microsoft PowerPoint
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
5d
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Senior Manager, External Manufacturing MSM Operations
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/yr HybridFull Time
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.
CAPA, PMI
1w
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Associate Process Engineer - Night Shift
Piscataway, New Jersey, United States
$65k-$80k/yr OnsiteFull Time
1+ YOEBachelor's degree in engineering, pharmaceutics, industrial pharmacy, or related field; 1+ year of relevant experience; process validation, manufacturing, statistical analysis, SOP, RCA, CAPA, FDA, and cGMP knowledge.
SOPs, CAPA, FDA, cGMP, RCA
5d
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Senior Manager, External Manufacturing MSM Operations
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/yr HybridFull Time
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.
CAPA, GMP, PMI
2mo
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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
1mo
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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.
2w
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Sr. Specialist, 880 Non Sterile Safety & Quality Compliance Operations (Onsite)
Rahway, New Jersey, United States
$117k-$184k/yr OnsiteFull Time
4+ YOEBachelor's in engineering/life sciences/chemistry,4+ years pharmaceutical/GMP manufacturing,experience with investigations/CAPAs/audits,cGMP knowledge,strong communication and project skills.
Veeva, SAP, MPS
1mo
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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
1mo
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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.
2w
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Sr. Specialist, 880 Non Sterile Safety & Quality Compliance Operations (Onsite)
Rahway, New Jersey, United States
$117k-$184k/yr OnsiteFull Time
4+ YOEBachelor's degree in engineering, life sciences, chemistry, or related field; 4+ years of pharmaceutical or GMP manufacturing experience; experience with investigations, CAPAs, audits, and quality systems.
Veeva, SAP
1mo
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TRD QA CGT Modality Head
East Hanover, New Jersey, United States
$176k-$328k/yr OnsiteFull Time
Provide global QA leadership for CGT modality, ensure GxP compliance, oversee audits/inspections, manage deviations/CAPA, and lead quality risk management and people.
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
3w
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Global Repair & Quality Manager
Elmsford, New York, United States
$90k-$110k/yr OnsiteFull Time
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.
ERP, RMA, QMS, BI, service-management systems
6d
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Senior Clinical Quality Operations Manager
Jersey City or Millbrae
$157k-$189k/yr HybridFull Time
8+ YOERequires 8+ years of related experience with a bachelor's degree or 6+ years with a postgraduate degree, plus GCP, CAPA, risk management, quality planning, and cross-functional clinical operations expertise.
Veeva
16h
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Quality Systems Specialist (ISO 9001 QMS Owner)
Hauppauge, New York, United States
$85k-$95k/yr OnsiteFull Time
7+ YOEBachelor’s degree or equivalent experience; 7+ years in quality systems or assurance; ISO 9001 QMS ownership; audit leadership; CAPA, root cause analysis, document control, and continuous improvement expertise.
ISO 9001, Quality Management System (QMS), TISAX, C-TPAT, QT9 QMS, ISO 27001, UL, ETL, DOT
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