43 capa jobs at 31 companies in Milford, CT
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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
2w
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Manufacturing Engineer
Middletown, Connecticut, United States
OnsiteFull Time
1+ YOEBachelor’s degree in engineering and 1–5 years of manufacturing, process, or quality engineering experience. Requires PFMEA, SPC, RCA, CAPA, office software proficiency, and U.S. citizenship.
Microsoft Excel, Microsoft Word, Microsoft PowerPoint, Microsoft Outlook, PFMEA, SPC, RCA, CAPA, 5-Whys, Fishbone, 8D, Cp/Cpk, CORE, Kaizen, 5S, Gemba, QAD
3d
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Senior Supplier Quality Engineer
Trumbull or Livingston
$100k-$125k/yr OnsiteFull Time
7+ YOERequires 7+ years in regulated quality environments, 5+ years in supplier quality management, and a bachelor's degree or equivalent experience. Expertise in supplier audits, risk management, SCAR/CAPA, regulatory standards, and quality systems.
FDA QSR (21 CFR 820), ISO 13485, EU MDR, ISO 14971, Minitab, Microsoft Office, ERP, eQMS, SCAR, CAPA, FMEA, NCMRs, SCNs, NPI, IQ, OQ, PQ, PPAP, QMS
3w
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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
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
1w
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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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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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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
1mo
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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
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.
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.
1d
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Validation Engineer
Windsor, Connecticut, United States
OnsiteFull Time
5+ YOEBachelor's degree in life sciences, engineering, or a related discipline; 5+ years of pharmaceutical or life sciences validation experience; technical writing, critical thinking, cGMP, CAPA, root-cause, risk assessment, and investigation expertise.
Microsoft Word, Microsoft Excel, Microsoft PowerPoint
2w
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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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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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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
3w
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Quality Assurance Manager
Bloomfield, Connecticut, United States
OnsiteFull Time
First Class Air Support: Distributes aftermarket aircraft components and provides aviation repair services.
7+ YOE3+ Mgmt7–10+ years in an FAA Part 145 repair station or aviation MRO, 3+ years leadership in quality/safety/inspection, knowledge of FAA/EASA regulations, ability to manage SMS, CAPA, audits, inspections, and airworthiness release processes.
FAA Form 8130-3, EASA Form 1, Safety Management System (SMS)
2w
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Regulatory Affairs/Quality Affairs Specialist
Baldwin, New York, United States
$75k-$87k/yr OnsiteFull Time
3+ YOEBachelor's in biomedical/RA/QA or related,3+ years FDA-regulated medical device experience,510(k) and post-market/CAPA experience,RAC preferred,audit and FDA/EU/ISO13485 knowledge,strong communication and PC skills.
2mo
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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, Quality Systems & Regulatory Affairs (Remote - East Coast)
Darien, Connecticut, United States
$160k-$180k/yr RemoteFull Time
8+ YOERequire 8+ years QA/RA medical device experience, bachelor’s degree, eQMS ownership experience (Greenlight Guru preferred), lead audits/inspections, FDA/EU regulatory submissions, and experience with CAPA, risk management, and document control.
Greenlight Guru
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