Design Quality Engineer (Andover, MA)

Job description

Life Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living. We are currently seeking a Design Quality Engineer to help maintain the design integrity, safety, performance, and quality of our Advanced Wound Management medical devices. This role plays a key part in ensuring new and existing products comply with global quality system regulations and applicable standards throughout the product lifecycle. What will you be doing?: Ensuring compliance with Design Control and Design Change activities independent of NPD and sustaining teams Reviewing and approving Design History Files (DHFs) and associated quality documentation Supporting verification and validation activities to ensure outputs meet design inputs Participating in risk analyses, design changes, and product testing activities Supporting the transfer of designs to manufacturing in collaboration with Operations and QA Reviewing and approving specifications for raw materials, intermediate products, and finished goods Generating and maintaining Risk Management Files in accordance with ISO 14971 Contributing to Health Hazard Evaluations and Safety & Efficacy Review Board activities as need...