Quality Engineer

Senior Design Assurance / Quality Assurance Engineer – NPD

We are partnering with an innovative medical device company seeking a Senior Design Assurance / Quality Assurance Engineer to lead Quality activities within New Product Development. This role sits at the core of product development, owning Design Quality and Design Controls from concept through design transfer and commercialization. The ideal candidate is a seasoned NPD Quality professional who thrives in high-pressure environments, operates independently, and brings deep expertise in risk management and Design Control execution.

• Lead Design Quality activities for new product development projects, ensuring full compliance with Design Controls requirements from concept through commercialization.
• Own and develop Design History File (DHF) deliverables, including quality plans, risk management documentation, verification/validation documentation, and phase gate reviews.
• Partner cross-functionally on core teams to drive risk management activities (ISO 14971), design reviews, and design transfer readiness.
• Provide hands‑on Quality leadership in validation, change control, and CAPA, ensuring timely and compliant execution in a fast‑paced environment.

• 5–7+ years of NPD Quality Engineering experience within the medical device industry.
• Strong, hands‑on expertise in Design Controls, Risk Management, DHF ownership, and design transfer.
• Proven ability to operate independently on core teams without heavy oversight; comfortable in high‑pressure, evolving project environments.