42 capa jobs at 28 companies in Danbury, CT

2mo
Save
Mark Applied
Hide
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
4w
Save
Mark Applied
Hide
Staff Design Quality Engineer
Leesburg or Allendale
$110k-$130k/yr HybridFull Time
VB Spine
VB Spine: A medical device focused on supporting surgeons and ensuring design and product quality throughout the product lifecycle.
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
Save
Mark Applied
Hide
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)
4w
Save
Mark Applied
Hide
Staff Quality Systems Specialist I
Franklin Lakes, New Jersey, United States
$136k-$217k/yr OnsiteFull Time
BD
BDNYSE: BDX: Manufactures medical devices, surgical instruments, and pharmacy automation systems.
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
2w
Save
Mark Applied
Hide
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
1w
Save
Mark Applied
Hide
Global Repair & Quality Manager
Elmsford, New York, United States
$90k-$110k/yr OnsiteFull Time
UE Systems
UE Systems: Provides ultrasonic instruments, software and training for predictive maintenance and condition monitoring to prevent downtime, reduce costs and save energy.
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
1d
Save
Mark Applied
Hide
Continuous Improvement Engineering Manager
West Haven, Connecticut, United States
$100k-$130k/yr OnsiteFull Time
Tirlán
Tirlán: Farmer-owned cooperative producing dairy, grain, and animal nutrition.
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
3w
Save
Mark Applied
Hide
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
1mo
Save
Mark Applied
Hide
FSQA Compliance & Systems Manager
Bronx, New York, United States
$90k-$110k/yr OnsiteFull Time
Baldor Specialty Foods
Baldor Specialty Foods: Distributor of fresh produce and specialty food products.
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
4w
Save
Mark Applied
Hide
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
3w
Save
Mark Applied
Hide
Registered Nurse- 2 M- Full-Time, Day Shift - 7 a- 7.30 p
Patchogue, New York, United States
$107k-$138k/yr OnsiteFull Time
NYU Langone Health
NYU Langone Health: Academic medical system providing comprehensive patient care and education.
Current New York RN license, BLS required; ACLS/PALS/TNCC/TCAR/CAPA as applicable; nursing diploma/associate required; BSN preferred; strong clinical assessment, communication, and documentation skills.
EHR
3w
Save
Mark Applied
Hide
Senior Packaging Engineer - North Haven
North Haven, Connecticut, United States
$98k-$148k/yr OnsiteFull Time
Medtronic
MedtronicNew York Stock Exchange: MDT: Develops and manufactures medical devices and digital health solutions.
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
Save
Mark Applied
Hide
Assistant Nurse Manager
Smithtown, New York, United States
$60-$75/hr OnsiteFull Time
Catholic Health
Catholic Health: Integrated healthcare system providing hospital and clinical medical services.
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
Save
Mark Applied
Hide
Senior R&D Manager - On-market
Orangeburg, New York, United States
$195k-$220k/yr OnsiteFull Time
Werfen
Werfen: Develops specialized diagnostic systems and reagents for clinical laboratories.
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.
3w
Save
Mark Applied
Hide
DPI Documentation Specialist Trainee
Hauppauge, New York, United States
$66k-$70k/yr OnsiteFull Time
Cipla
CiplaNational Stock Exchange of India: CIPLA: Manufactures and sells generic medicines and active pharmaceutical ingredients
1+ YOEAssociate degree with GMP documentation experience, 1+ year documentation and 3+ years pharma/biotech experience preferred; proficiency in cGMP/GDP, SOPs, CAPA, deviations; MS Word/Excel and document systems experience.
Microsoft Office Suite, Microsoft Word, Microsoft Excel, SAP, MasterControl, TrackWise, Master Control
1w
Save
Mark Applied
Hide
Quality Manager (Distribution)
Ronkonkoma, New York, United States
$115k-$125k/yr OnsiteFull Time
Nestlé
NestléSIX Swiss Exchange: NESN: Produces and sells a wide range of food and beverages.
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
Save
Mark Applied
Hide
Director, Data Management Process, Quality & Inspection Readiness
Warren or Tarrytown or Armonk
$183k-$305k/yr HybridFull Time
Regeneron Pharmaceuticals
Regeneron PharmaceuticalsNASDAQ: REGN: Discovers and develops medicines for serious diseases.
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
Save
Mark Applied
Hide
Quality Manager
South Hackensack or Mahwah
$150k-$180k/yr OnsiteFull Time
HYTORC
HYTORC: Manufactures and services industrial hydraulic and pneumatic bolting systems.
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
Save
Mark Applied
Hide
Director, Data Management Process, Quality & Inspection Readiness
Warren or Tarrytown or Armonk
$183k-$305k/yr HybridFull Time
Regeneron
RegeneronNasdaq: REGN: Discovers and manufactures medicines for serious diseases.
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
2w
Save
Mark Applied
Hide
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)