Job Description
Job Title: Supplier Quality Engineer II
Job ID: 27298
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)
Numbers & Facts
| Location | North Haven, CT |
| Salary | $45–$50 Per Hour |
Skills
Change Managementunmatched
Change Requests/Ordersunmatched
Code of Federal Regulationsunmatched
Contract Manufacturingunmatched
Corrective Actionunmatched
Corrective and Preventative Action (CAPA) Systemsunmatched
Cross-Functionalunmatched
Documentationunmatched
Electronicsunmatched
FDA (Food and Drug Administration)unmatched
Failure Mode and Effects Analysis (FMEA)unmatched
GMP (Good Manufacturing Practices)unmatched
ISO (International Organization for Standardization)unmatched
Manufacturingunmatched
Medical Equipmentunmatched
Process Failure Mode and Effects Analysis (PFMEA)unmatched
Production Part Approval Process (PPAP)unmatched
Quality Controlunmatched
Quality Engineeringunmatched
Root Cause Analysisunmatched
Statisticsunmatched
Testingunmatched
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