More jobs:
Quality Engineer II
Job in
North Haven, New Haven County, Connecticut, 06473, USA
Listed on 2026-07-31
Listing for:
Artech LLC
Full Time
position Listed on 2026-07-31
Job specializations:
-
Engineering
Quality Engineering, Biomedical Engineer, Process Engineer, Regulatory Compliance Specialist -
Quality Assurance - QA/QC
Quality Engineering, Regulatory Compliance Specialist
Job Description & How to Apply Below
Job Title:
Supplier Quality Engineer II
Job
Duration: 12 Months
Location:
North Haven Connecticut 06473
Pay Rate: $45.00 - $50.00/hr on W2
Key Skills:
- Supplier Quality Engineering in Medical Device industry
- Supplier Change Requests (SCR), PPAP, Validation, TMV, SCAPA, QMS
- Quality Plans, Control Plans, PFMEA/FMEA, MSA
- Supplier qualification, part/process qualification, and change management
- Contract Manufacturer (CM) management and supplier development
- CAPA, root cause analysis, corrective/preventive actions
- ISO 13485, FDA 21 CFR Part 820, GMP compliance
- Inspection, testing, statistical analysis, and quality documentation
- Cross-functional collaboration with Engineering, Manufacturing, and Suppliers
Requirements:
- Bachelor's degree in Engineering, Scientific, Electronics, or related technical field
- 2+ years relevant experience (4+ years preferred)
- Medical Device industry experience required
- Onsite in North Haven, CT (40 hrs/week)
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