Senior Quality Engineer - Design Assurance

**Job Description Summary**
As a Design Assurance Quality Engineer (QE), you will play a key role in ensuring that new product development and sustaining projects meet stringent quality and compliance standards. Acting as the Quality representative on project core teams, you will oversee design controls, risk management, and change control processes while driving adherence to global regulatory requirements. Your responsibilities will span from product inception through launch and maintenance, requiring strong collaboration with cross-functional teams and effective communication skills.

You will lead risk management activities, manage Design History File (DHF) documentation, and support compliance initiatives such as IEC 60601 and IEC 62304. The role involves reviewing and approving verification and validation plans, challenging statistical rationales, and authorizing deviations. You will also assist in failure investigations, software issue tracking, and advocate for a stro...