Job Description
Role and Responsibilities Quality System
- Develop, implement and maintain QMS documentation to maintain compliance with applicable standards such as ISO 9001, ISO 13485 or GMP
- Monitor regulatory changes and update the QMS accordingly
- Conduct internal audits and support external audits (external auditing bodies, suppliers and customers)
- Analyze quality data and metrics to identify trends and areas for improvement
- Collaborate with cross functional teams to ensure that the quality standards are integrated into processes
- Reports on QMS performance to top management and recommend improvement
- Point of contact for certification bodies
- Lead Management Review and follow up action items
- Analyze and capture recurring product complaints, collaborate with Operation and Technology teams to address compound...