Responsibilities:
- Lead the development, execution and improvement of quality system in relation to ISO 13485
- Lead and implement strategies for Quality Team
- Communicate with internal stakeholders of design controls, design verification and validation activities
- Support product release process or reviewing and approving requests for product release
Requirements:
- Diploma/Degree in Engineering (Mechanical, Chemical, Bioengineering)
- More than 8 years of medical device experience with design and documentation quality, QMS, GMP, Audit and CAPA
- More than 5 years of experience in a leadership role
- Familiar with ISO 13485, ISO 14971, ISO 10993, IEC 60601