26 capa jobs at 21 companies in Meriden, 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
2w
Save
Mark Applied
Hide
Quality Supervisor
Pomfret, Connecticut, United States
$75k-$90k/yr OnsiteFull Time
Loos & Co
Loos & Co: Manufactures mission-critical wire, rope, and cable assemblies.
10+ YOE10+ years quality experience in AS9100 manufacturing, supervisory experience, inspection and measurement skills, root cause analysis, CAPA, strong communication, and Microsoft Office proficiency.
Microsoft Office, 8D, 5 Why, Fishbone Diagrams, SPC, FMEA, MSA, CAPA
2d
Save
Mark Applied
Hide
Senior Supplier Quality Engineer
Trumbull or Livingston
$100k-$125k/yr OnsiteFull Time
CooperSurgical
CooperSurgicalNasdaq: COO: Manufactures medical devices for fertility and women's health.
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
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)
1mo
Save
Mark Applied
Hide
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
3w
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
1mo
Save
Mark Applied
Hide
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.
1w
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
1mo
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
4w
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
1w
Save
Mark Applied
Hide
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
3w
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)
1mo
Save
Mark Applied
Hide
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
Save
Mark Applied
Hide
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
2d
Save
Mark Applied
Hide
Manager, Expanded Access Program
New Haven, Connecticut, United States
$116k-$151k/yr OnsiteFull Time
Celldex Therapeutics
Celldex TherapeuticsNASDAQ: CLDX: Developing antibody-based immunotherapies for inflammatory and autoimmune diseases.
3+ YOEBachelor's degree or equivalent experience; 5–8 years in biotechnology or pharmaceuticals, including 3+ years in clinical or medical operations. Requires vendor oversight, global program, regulatory, metrics, and project management experience.
GxP, Standard Operating Procedures (SOPs), 21 CFR Part 312, Key Performance Indicators (KPIs), Service Level Agreements (SLAs), Corrective and Preventive Action (CAPA)
5d
Save
Mark Applied
Hide
QC Manager
Plainville, Connecticut, United States
$110k-$125k/yr OnsiteFull Time
ALK-Abelló
ALK-AbellóNasdaq Copenhagen: ALKB: Developing and manufacturing allergy immunotherapy and diagnostic products.
5+ YOE5+ MgmtPreferred bachelor's degree in life sciences, biology, chemistry, or related field; 5+ years of progressive laboratory management experience in pharmaceutical or GMP settings; knowledge of cGMP, USP, FDA, and ICH guidelines.
GxP, ILT, SOPs, WINs, CAPAs, FDA, Health Canada, USP, ICH, cGMP, pH meter, UV/vis spectrophotometer
2mo
Save
Mark Applied
Hide
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
1w
Save
Mark Applied
Hide
Quality System Manager - Remote
Farmington, Connecticut, United States
$86k-$130k/yr RemoteFull Time
The Jackson Laboratory
The Jackson Laboratory: Conducts genomic research and produces specialized laboratory mouse models.
7+ YOE2+ MgmtBachelor's degree, 7 years of quality experience, 2 years of supervisory experience, risk management and quality systems expertise, ISO 9001 knowledge, and pharmaceutical or biotechnology leadership experience.
Design FMEA, Process FMEA, pFMEA, Root Cause Analysis (RCA), MSA/Gauge R&R, ISO 9001, Computer System Validation, Quality by Design (QbD), Lean, Six Sigma, CAPA
3mo
Save
Mark Applied
Hide
Sanitation Manager
East Moriches, New York, United States
$97k-$134k/yr OnsiteFull Time
Mondelēz International
Mondelēz InternationalNasdaq: MDLZ: Global manufacturer of chocolate, biscuits, and snack food products.
3+ YOELead sanitation and pest control programs; ensure GMP, HACCP, PEM compliance; manage sanitation team; coordinate QA and food safety functions.
HACCP, GMP, PEM, CAPA, Pest Control Software
1mo
Save
Mark Applied
Hide
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