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Responsibilities
- Participate in and support internal and/or external audits and inspections to demonstrate compliance with regulations and standards such as QMS Ordinances No.169, ISO13485, and MDSAP.
- Organize and review processes, Quality Manual, Standard Operating Procedures, Working Instructions, and QMS records to ensure regulatory compliance.
- Evaluate the necessity of actions (CAPA, regulatory reporting, field action, improvement) for identified non-conformances and complaints, and manage these actions.
- Implement improvements in QMS and Vigilance processes to align with regulatory requirements, corporate policies, and environmental changes.
- Contribute expertise in quality and safety of Medical Devices, IVDs, and other products within cross-functional teams for new product introductions.