Job Description
Summary:
Roles and Responsibilities:
- Responsible for ensuring compliance with established requirements and standards for products and processes through effective implementation of the Quality Management System (QMS).
- The position is responsible for supporting the global development, implementation, and continuous improvement and harmonization of the local Quality Management System (QMS) in compliance with applicable medical device regulations and standards, including FDA 21 CFR Part 820, ISO 13485, IEC 62304 and EU MDR as well as corporate procedures and requirements.
- What You Can Expect How You'll Create Impact Principal
Roles and Responsibilities:
- Support cross-functional teams in the harmonization and standardization of quality procedures, tools, and best practices across sites and regions.
- Complete gap assessments for local procedures...