Job Title: Supplier Quality Engineer – Medical Device
Location: North Haven, CT (Fully Onsite)
Type: W2 Contract | Duration: 1 Year
Key Skills:
✔ Supplier Change Requests (SCR), PPAP, CAPA, QMS
✔ Validation, TMV, MSA, SPC, FMEA, Control Plans
✔ ISO 13485, 21 CFR 820 compliance
✔ Contract Manufacturer (CM) management
✔ Supplier audits, Supplier Performance Management
✔ NPD collaboration, Design Controls, Risk Management
✔ Electronics Qualification (preferred) | 6 Sigma / Lean (preferred)
Role Overview:
Seeking an experienced Supplier Quality Engineer to lead and support supplier quality processes for finished goods Contract Manufacturers (CMs) in a Medical Device environment. Responsibilities include supplier selection, qualification, audits, CAPAs, SCRs, and working cross-functionally to ensure compliance with ISO 13485 and 21 CFR 820 standards.
Qualifications:
Bachelor's in Engineering/Scientific/Technical field
4+ years relevant experience (or 2+ years with advanced degree)
Lead Auditor (ISO 13485) preferred | Lean / Six Sigma trained/certified preferred.
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