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Senior Quality Engineer - Medical Devices (Onsite

Job in North Haven, New Haven County, Connecticut, 06473, USA
Listing for: Intellectt INC
Full Time position
Listed on 2026-08-06
Job specializations:
  • Engineering
    Quality Engineering, Regulatory Compliance Specialist
  • Quality Assurance - QA/QC
    Quality Engineering, Regulatory Compliance Specialist
Salary/Wage Range or Industry Benchmark: 90000 - 130000 USD Yearly USD 90000.00 130000.00 YEAR
Job Description & How to Apply Below
Position: Senior Quality Engineer - Medical Devices (Onsite)

Intellectt Inc. is seeking a Senior Quality Engineer for an onsite role in North Haven, CT. The candidate will support manufacturing and product quality improvements, lead investigations, and perform root-cause analyses with CAPA and NCR processes.

The role requires experience with process validation, IQ/OQ/PQ, and equipment qualification, plus strong knowledge of regulatory standards such as FDA 21 CFR Part 820 and ISO 13485. Collaboration across cross-functional teams is essential.

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Position Requirements
10+ Years work experience
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