Sr Quality Engineer – Medical Device (Design Focus)

Hiring: Sr Quality Engineer – Medical Device (Design Focus)Location: Raritan, NJ (Hybrid – 3 days onsite)Type: Contract (through end of year)Potential: Opportunity for full-time conversion (GC preferred)Rate: $45/hr on W2 (No benefits)About the RoleWe are looking for a Senior Quality Engineer to support a packaging design change project. This role is heavily focused on design quality, validation, and design controls rather than manufacturing.Key Responsibilities• Lead/support design control & design validation activities• Drive product & process validation (IQ/OQ/PQ)• Perform risk management (FMEA, root cause analysis)• Support design verification protocols & statistical analysis• Oversee component qualification at suppliers• Collaborate with cross-functional teams across lifecycle projectsTop Skills Required✔ Design Controls & Design Validation✔ Medical Device Design Change Experience✔ Risk Management & Validation (FMEA, IQ/OQ/PQ)Must-Have• Experience as Design Quality or R&D Engineer in medical devices• Strong understanding of design control processes• Experience with validation protocols & statistical analysisNice to Have• Six Sigma / Lean methodologies• Supplier quality & external validation experience• Packaging project experience.