Supplier Quality Engineer Medical Device

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.