42 capa jobs at 31 companies in Bridgeport, CT
2w
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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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Quality Management System (QMS) Engineer
Torrington, Connecticut, United States
$70k-$100k/yr OnsiteFull Time
3+ YOELead and maintain QMS, CAPA, NCR, audits; ensure FDA/ISO compliance in regulated medical device manufacturing.
eQMS, CAPA system, document control software
1mo
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Supplier Quality Manager
Brookfield or Danbury
OnsiteFull Time
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)
2w
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Supplier Quality Engineer
Guilford, Connecticut, United States
$107k-$123k/yr OnsiteFull Time
5+ YOELead supplier quality activities including supplier qualification, audits, NCs/CAPAs/SCARs, product release, risk management, and continuous improvement in a regulated medical device environment.
Microsoft Office, ERP, eQMS
2w
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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
2d
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Continuous Improvement Engineering Manager
West Haven, Connecticut, United States
$100k-$130k/yr OnsiteFull Time
5+ YOEBachelor's degree in engineering or a related technical field, 5+ years in manufacturing, quality, process engineering, or continuous improvement, and CAPA, root cause analysis, statistical analysis, and project leadership experience.
5 Why, Fishbone, Fault Tree Analysis, Lean Manufacturing, Six Sigma, Kaizen, Statistical Process Control (SPC), Minitab, Microsoft Power BI, HACCP, FDA, GMP
1mo
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Senior Quality Engineer
North Haven, Connecticut, United States
$98k-$148k/yr OnsiteFull Time
0+ YOEBachelor's in engineering/science +4yrs (or advanced degree +2yrs, or PhD), experience in engineering/quality, process validation, root cause/CAPA, statistical analysis (e.g., Minitab), and regulated manufacturing (FDA/CFR).
Minitab
4w
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Quality Specialist, Assoc
New Britain, Connecticut, United States
$21-$23/hr OnsiteFull Time
1+ YOEInspect materials and products, perform measurements and tests, document results, identify non-conformances, support CAPA, read blueprints, and use measuring instruments; 1-2 years inspection experience preferred.
calipers, micrometers, gauges, testing equipment
1mo
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FSQA Compliance & Systems Manager
Bronx, New York, United States
$90k-$110k/yr OnsiteFull Time
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
3w
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Senior Packaging Engineer - North Haven
North Haven, Connecticut, United States
$98k-$148k/yr OnsiteFull Time
4+ YOEDegree in packaging/mechanical/manufacturing engineering, 4+ years experience (Bachelors) or equivalent, experience in regulated packaging operations, IQ/OQ/PQ validation, CAPA, Lean/Six Sigma, and project management skills.
IQ, OQ, PQ, Lean Manufacturing, Six Sigma
4w
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Supplier Quality Engineer Lead
Trumbull or Livingston
$120k-$150k/yr OnsiteFull Time
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
2mo
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Senior R&D Manager - On-market
Orangeburg, New York, United States
$195k-$220k/yr OnsiteFull Time
10+ YOE7+ MgmtAdvanced degree in relevant field, 10+ years relevant experience (PhD+10 or Master's+15), 7+ years managing scientists/engineers, knowledge of complaint and CAPA procedures, regulatory and QA interaction, technical leadership.
1mo
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Assistant Nurse Manager
Smithtown, New York, United States
$60-$75/hr OnsiteFull Time
3+ YOEBSN required; RN license and BLS and ACLS required; PALS and specialty certs (CNOR/CAPA/CPAN/RCIS) preferred; 3–5 years perioperative nursing experience; knowledge of perioperative workflows and regulatory standards.
1w
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Quality Manager (Distribution)
Ronkonkoma, New York, United States
$115k-$125k/yr OnsiteFull Time
7+ YOE7+ years in food/dietary supplement/pharma quality, strong cGMP/FDA knowledge, HACCP/GFSI experience, team leadership, QMS/CAPA/SPC expertise, SAP and Microsoft Office proficiency, ~20% travel.
Microsoft Word, Microsoft Excel, Microsoft PowerPoint, SAP
1mo
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Quality Systems Specialist
Allendale or Leesburg
$75k-$85k/yr HybridFull Time
Bachelor's degree required; knowledge of US and international medical device regulations, QMS elements (CAPA, audits, management review), strong communication, analytical and project skills, computer literate; ability to travel 10-15%.
1mo
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Director, Data Management Process, Quality & Inspection Readiness
Warren or Tarrytown or Armonk
$183k-$305k/yr HybridFull Time
12+ YOE5+ MgmtBachelor's degree and 12+ years clinical data management experience, 5+ years people management, expertise in GCP/ICH/21 CFR Part 11/ALCOA+, inspection readiness, quality frameworks, CAPA and process governance.
SharePoint
1mo
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Quality Manager
South Hackensack or Mahwah
$150k-$180k/yr OnsiteFull Time
7+ YOE3+ MgmtBachelor's in engineering/quality or equivalent, 7+ years quality experience in manufacturing/machining, 3+ years managing quality personnel, strong QMS/audit/CAPA experience, ISO 9001/17025 knowledge, ASQ certifications and Minitab preferred.
Microsoft Office, Minitab
1mo
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Sr. Manager/Associate Director, Quality Control
New York City, New York, United States
$140k-$200k/yr OnsiteFull Time
10+ YOE3+ MgmtBS in chemistry/biology required (advanced degree preferred); 10+ years QC in a GMP lab; 3+ years supervisory experience; strong knowledge of cGMP/FDA/EMA; experience with investigations, CAPA, method validation, and CMO oversight.
1mo
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Mechanical Inspection Manager - Aerospace Machining
Medford, New York, United States
$30-$45/hr OnsiteFull Time
5+ YOE5+ years QC management/supervisory experience in a precision CNC machine shop, advanced blueprint reading, GD&T, CMM programming/operation, FAI/MRB/CAPA experience, working knowledge of AS9100/ISO9001; U.S. Person required.
CMM, GD&T
1mo
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Director, Data Management Process, Quality & Inspection Readiness
Warren or Tarrytown or Armonk
$183k-$305k/yr HybridFull Time
12+ YOE5+ MgmtBachelor's degree and 12+ years in clinical data management, 5+ years people management; expert knowledge of GCP/ICH/21 CFR Part 11, inspection readiness, CAPA, KPI/KQI frameworks, process governance and change management.
Microsoft SharePoint
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