Job Description:
The role of Senior Design Assurance/Risk Management Specialist is to be the QA technical and compliance expert as part of a cross-functional team for the design and development of sterile and non-sterile medical devices.
Lead risk assessments, device testing, audits (internal and external), support as SME for design processes. Generate and/or approve technical documents on behalf of the Quality Function. Manage Device History File (DHF).
* Audit lead/sponsor
* Mentorship/training
* SME Technical writing
* DHF Manager/lead auditor