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 Role
We 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 projects
Top 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 analysis
Nice to Have
• Six Sigma / Lean methodologies
• Supplier quality & external validation experience
• Packaging project experience.