68 fda jobs at 34 companies in Glastonbury, CT
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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
1w
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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
1w
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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)
3d
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Prin Quality Engineer
Lafayette or North Haven or Boston or Minneapolis or Los Angeles County
$121k-$181k/yr OnsiteFull Time
Bachelor's degree in engineering or related technical field; in-depth FDA, ISO 13485, and ISO 14971 knowledge; quality, risk management, regulatory, statistics, root-cause analysis, leadership, and project management expertise.
FDA, ISO 13485, ISO 14971, ISO 62304, FDA Part 820, Design Failure Modes and Effects Analyses (DFMEAs), Process FMEA, User FMEA
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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
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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.
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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.
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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
1w
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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
2w
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Plant Manager
Putnam, Connecticut, United States
OnsiteFull Time
10+ YOEBachelor's degree or equivalent experience,10+ years manufacturing leadership,budget and capital project experience,lean/continuous improvement and safety leadership,experience with FDA/GMP preferred.
1w
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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
5d
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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
5d
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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
5d
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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, strategy, analytics, vendor management, compliance, and cross-functional leadership.
Snowflake, SQL, Python, R
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
1mo
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Continuous Improvement Engineer II
Bethel, Connecticut, United States
$64k-$94k/yr OnsiteFull Time
5+ YOE5+ years in regulated (FDA/ISO) environment, BS in engineering/science required (MS preferred), Lean Black Belt, strong leadership, project management, analytics, and ISO quality systems knowledge.
2mo
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Senior Clinical Data Manager
New Haven, Connecticut, United States
$134k-$173k/yr OnsiteFull Time
5+ YOEBA/BS required; 5+ years clinical data management experience; proficiency in Medidata Rave; knowledge of CDISC and FDA regulations; strong Excel/Word/Outlook skills; excellent communication and organizational abilities.
Medidata Rave, Microsoft Excel, Microsoft Word, Microsoft Outlook
2w
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Supervisor Quality Control
Dayville, Connecticut, United States
OnsiteFull Time
2+ YOE2+ years QC or laboratory experience in manufacturing/medical, knowledge of ISO/FDA/cGMP and good documentation practices, strong leadership, ability to read engineering drawings and SDS, high school diploma or equivalent.