20 capa jobs at 16 companies in Bristol, CT

2mo
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Quality Management System (QMS) Engineer
Torrington, Connecticut, United States
$70k-$100k/yr OnsiteFull Time
Aptyx
Aptyx: Manufacturer of complex components for medical and industrial applications.
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
Greenfield Global
Greenfield Global: Produces high-purity alcohols, specialty solvents, and sustainable biofuels.
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
Hyperfine
HyperfineNasdaq: HYPR: Develops and sells portable MRI brain imaging systems.
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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Quality Assurance Administrator
New London, Connecticut, United States
$20-$23/hr OnsiteFull Time
Sheffield Pharmaceuticals
Sheffield Pharmaceuticals: Manufacturer of over-the-counter pharmaceuticals and personal care products.
Maintain QA documentation, review batch records, coordinate CAPAs and audits. Requires attention to detail, knowledge of cGMP and good documentation practices, and proficiency with Word, Excel, and PowerPoint.
Microsoft Word, Microsoft Excel, Microsoft PowerPoint
1mo
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Quality Engineer II
Canaan, Connecticut, United States
OnsiteFull Time
BD
BDNYSE: BDX: Manufactures medical devices, surgical instruments, and pharmacy automation systems.
3+ YOEBachelor's degree, 3 years manufacturing experience, strong problem-solving and CI skills, experience with process validation, CAPA, change control, and manufacturing quality support for 24/7 operations.
3w
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Quality Specialist, Assoc
New Britain, Connecticut, United States
$21-$23/hr OnsiteFull Time
Curtiss-Wright
Curtiss-WrightNYSE: CW: Engineers and manufactures critical components for aerospace and defense.
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
4w
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Supplier Quality Engineer Lead
Trumbull or Livingston
$120k-$150k/yr OnsiteFull Time
CooperSurgical
CooperSurgicalNasdaq: COO: Manufactures medical devices for fertility and women's health.
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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Quality Engineer
Brimfield, Massachusetts, United States
$70k-$95k/yr OnsiteFull Time
Viant
Viant: Designs and manufactures complex medical devices for global OEMs.
2+ YOEBachelor's in engineering or 2–5 years quality engineering in regulated/medical device manufacturing; knowledge of QMS/regulatory standards; proficiency with Microsoft Office and Minitab; experience with validations, CAPA, and statistical quality tools.
Microsoft Office, Minitab
5d
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Perianesthesia RN - ASU/PACU
New London, Connecticut, United States
OnsitePart Time
Yale New Haven Health
Yale New Haven Health: Providing comprehensive medical care and teaching hospital services.
2+ YOEActive CT RN license, BLS/ACLS/PALS required, CAPA/CPAN preferred, graduate of nursing program, 2 years critical care experience preferred, EMR proficiency, strong communication and critical thinking.
Electronic Patient Records
5d
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Perianesthesia RN - ASU/PACU
New London, Connecticut, United States
OnsitePart Time
Yale New Haven Health
Yale New Haven Health: Operates a network of hospitals and healthcare facilities.
Active Connecticut RN license, ACLS/BLS/PALS required, specialty certification (CAPA/CPAN) preferred, graduate of accredited nursing program, critical care or PACU/ASU experience preferred, proficient with electronic patient records.
Electronic Patient Records
2w
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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)
1mo
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Director, Quality Systems & Regulatory Affairs (Remote - East Coast)
Darien, Connecticut, United States
$160k-$180k/yr RemoteFull Time
CEFALY Technology
CEFALY Technology: Manufacturer of wearable medical devices for migraine relief.
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
1mo
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Development Scientist II, Analytical Development and Clinical QC (ADQC)
New Haven, Connecticut, United States
OnsiteFull Time
AstraZeneca
AstraZenecaLondon Stock Exchange: AZN: Global biopharmaceutical developing and manufacturing prescription medicines.
2+ YOEAdvanced MS or PhD in biochemistry/chemistry or related field, 2+ years (PhD) or 10+ years (MS) hands-on analytical development experience, cGMP/QC knowledge, LIR/CAPA investigation skills, MS Office proficiency, strong analytical and communication skills.
Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Veeva Vault (EQV), LIMS, ValGenesis, Kneat, JMP, Tableau, SAS, Microsoft SharePoint, BOX
1mo
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Development Scientist II, Analytical Development and Clinical QC (ADQC)
New Haven, Connecticut, United States
OnsiteFull Time
Alexion Pharmaceuticals
Alexion Pharmaceuticals: Develops and manufactures treatments for rare and ultra-rare diseases.
2+ YOEResponsible for owning laboratory investigations (LIRs), closing OOS/OOT investigations, performing root cause analysis and CAPA, reviewing analytical data, ensuring cGMP compliance, and collaborating with QA/AD/stability; advanced degree in biochemistry/chemistry (MS or PhD) with relevant analytical development experience required.
Veeva Vault (EQV), LIMS, ValGenesis, Kneat, JMP, Tableau, SAS, Microsoft SharePoint, Microsoft Word, Microsoft Excel, Microsoft PowerPoint
2mo
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Quality Manager
West Springfiield, Massachusetts, United States
$90k-$110k/yr OnsiteFull Time
Valence Surface Technologies
Valence Surface Technologies: Provides surface finishing and chemical processing for aerospace components.
15+ YOE15+ years aerospace quality leadership; Bachelor's degree (preferred); NADCAP experience; manage quality metrics and audits; cross-functional leadership.
NADCAP, ERP, Root cause analysis, CAPA
1mo
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Manufacturing R&D Engineer
Wallingford or Durham
OnsiteFull Time
Vantedge Medical
Vantedge Medical: Manufacturer of precision metal components for medical device OEMs.
10+ YOE10+ years in manufacturing/process development/R&D engineering, experience with PECM/ECF and GD&T, strong project management, problem solving, and documentation skills; bachelor’s degree in engineering required.
Pulsed Electro-Chemical Machining (PECM), Electro-Chemical Finishing (ECF), GD&T, CAPA, 6S
1mo
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Senior Quality Engineer
Danbury, Connecticut, United States
$100k-$115k/yr OnsiteFull Time
908 Devices
908 DevicesNASDAQ: MASS: Handheld mass spectrometry devices for on-site chemical analysis.
5+ YOEBachelor's in engineering (Masters preferred), 5+ years quality engineering in electromechanical manufacturing, experience leading root cause analysis and corrective actions, familiarity with ISO 9001 and IPC-A-610, structured problem-solving (8D, FMEA, SPC), <10% travel.
8D, 5 Whys, Fishbone, DOE, SPC, FMEA, CAPA, Lean, Six Sigma, Kaizen
1mo
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Manufacturing Manager Electrode Production (Torrington, CT, US, 06790)
Torrington, Connecticut, United States
OnsiteFull Time
FuelCell Energy
FuelCell EnergyNASDAQ: FCEL: Produces fuel cell power plants and hydrogen generation systems.
7+ YOE3+ MgmtB.S. in engineering required, 7+ years manufacturing/process experience with 3+ years supervisory experience; lean manufacturing proficiency, experience in chemical/ceramic/powder or electrode manufacturing, and ability to lead 24/7 production teams.
VSM, Kaizen, 5S, PDCA, PLM, ERP, MES, SPC, OEE, CAPA