67 fda jobs at 38 companies in Meriden, CT
2mo
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Clinical Research Coordinator 2
New Haven, Connecticut, United States
$65k-$101k/yr OnsiteFull Time
2+ YOECoordinate clinical trials; manage screening, eligibility, recruitment; ensure compliance with GCP, FDA, HIPAA; independent multi-study management; strong communication.
GCP, FDA Regulations, HIPAA, EMR, Clinical Trial Management Systems
6d
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Prin Regulatory Affairs Spec - Core Surgical innovations
Lafayette or Mansfield or Mounds View or North Haven or Boston
$120k-$180k/yr OnsiteFull Time
5+ YOEBachelor's degree and 7+ years or advanced degree and 5+ years in regulatory affairs; medical device, FDA, EU, ISO, audits, submissions, leadership, and communication experience required.
FDA, Medical Device Directive (93/42/EEC), Medical Device Regulation (EU 2017/745), ISO 14971, ISO 13485, artificial intelligence, machine learning
5d
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Process Development Technician II
Enfield, Connecticut, United States
$32-$35/hr OnsiteFull Time
3+ YOEHigh school diploma or GED, 3+ years in medical device engineering or manufacturing, process development experience, FDA/cGMP and ISO knowledge, technical drawing skills, and fluent English.
Microsoft software, Pro-E, CREO, SolidWorks, DMAIC, PPE, ISO 9001, ISO 13485, FDA, cGMP
5d
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QC Manager
Plainville, Connecticut, United States
$110k-$125k/yr OnsiteFull Time
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
1mo
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Quality Engineer (Bridgeport, CT, US, 06610-0156)
Bridgeport, Connecticut, United States
OnsiteFull Time
3+ YOEBachelor's in engineering, 3+ years quality experience with metrology/CMM, GD&T, SPC/DOE, ISO and FDA QSR knowledge, blueprint reading, statistical analysis, and ability to lead inspections and corrective actions.
CMM, optical comparators, micrometers, calipers, gage blocks, pin gages, Gage R&R, GD&T, DOE, SPC, ISO, FDA, ECNs, SCRs, Material Review Board (MRB)
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
2mo
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Operations Supervisor
Windsor, Connecticut, United States
OnsiteFull Time
3+ YOE3+ MgmtBachelor’s degree + 3+ years distribution/warehouse management; 3+ years supervisory; pharma warehousing and HazMat preferred; FDA/cGMP familiarity
Tecsys Elite, MQ1, Outlook, Excel, PowerPoint, TECSYS, UKG
4w
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Principal Microbiologist
Stamford or Trumbull
$110k-$120k/yr OnsiteFull Time
10+ YOE10+ years industry microbiology experience with preservation, antibacterial product development, regulatory interpretation (FDA), complex study design, manufacturing microbiology, and leadership.
2mo
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Compounding Inspector
New London, Connecticut, United States
$18-$20/hr OnsiteFull Time
High school diploma; ability to work 3rd shift; knowledge of cGMP/FDA/GLP; basic lab skills; English proficiency; strong record-keeping.
1mo
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Product Development Manager (5703)
Windsor Locks, Connecticut, United States
OnsiteFull Time
Lead product development for medical films and nonwovens, oversee design transfers, manage projects and trials, understand film chemistry and FDA/ISO awareness, and travel as needed.
Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Microsoft Outlook, Microsoft Teams
3w
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Prin Regulatory Affairs Spec
North Haven or Mansfield or Mounds View or Boston or Lafayette
$120k-$180k/yr OnsiteFull Time
7+ YOEBachelor's degree and 7+ years regulatory experience (or advanced degree with 5+ years). Experience with 510(k), FDA interactions, international registrations, labeling and promotional material review.
4d
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Quality & Compliance Manager
Doylestown or New Britain or Exeter or Seabrook
OnsiteFull Time
5+ YOERequires 5+ years in senior medical device or pharmaceutical quality assurance, FDA or Notified Body inspection experience, people management, Microsoft Office proficiency, and fluent English.
Microsoft Office
5d
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Senior QA Inspector
Southington, Connecticut, United States
OnsiteFull Time
2+ YOEHigh school diploma or GED, 2+ years in FDA-regulated manufacturing, strong math and records-filing skills, computer proficiency, and ability to lift up to 20 pounds.
iFactory, Oracle, Oracle Installed Base, email
1d
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Director, Commercial REMS Operations - Pharmaceutical
Boston or New Haven
$216k-$260k/yr HybridFull Time
7+ YOEBachelor’s degree and 7+ years supporting pharmaceutical or biotechnology REMS programs, including commercial FDA REMS experience, cross-functional governance, analytics, vendor management, and executive communication.
Snowflake, SQL, Python, R
1d
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Director, Commercial REMS Operations - Pharmaceutical
Boston or New Haven
$216k-$260k/yr HybridFull Time
7+ YOEBachelor’s degree and 7+ years supporting pharmaceutical or biotechnology REMS programs, including commercial FDA REMS experience, cross-functional leadership, analytics, vendor management, and executive communication.
Snowflake, SQL, Python, R
2mo
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ERP Operations Analyst
Bethel, Connecticut, United States
$78k-$113k/yr OnsiteFull Time
7+ YOE5+ Mgmt7+ years manufacturing; 5+ years in manufacturing/inventory management; lean tools knowledge; ERP experience; FDA/GMP/ISO 13485 knowledge; strong communication and analytical skills.
Epicor ERP, QAD, Microsoft Office
2w
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Office Manager
Trumbull, Connecticut, United States
OnsiteFull Time
5+ YOE5+ Mgmt5+ years supervisory experience in healthcare, HS/GED required, college degree preferred; knowledge of FDA/ACR/MQSA standards; ability to monitor all shifts and manage radiology operations.
2mo
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Copy of Quality Inspector
Shelton, Connecticut, United States
OnsiteFull Time
3+ YOEInspect incoming, in-process, and final goods; read blueprints; 3-5 years in quality/manufacturing; ISO 13485 and FDA GMP knowledge; lift up to 50 lbs; proficient with MS Office.
Calipers, Optical comparators, Microsoft Office Suite
2mo
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Clinical Risk Manager
Hartford, Connecticut, United States
OnsiteFull Time
Requires active RN license, bachelor’s degree in nursing/healthcare or related (master’s preferred), experience in medical risk management and leadership preferred, knowledge of Joint Commission, FDA, OSHA, and strong communication skills.
1mo
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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
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