QA Specialist

Job Description

- Participate and support internal and/or external audits, inspections, or surveillance to demonstrate compliance with the regulations or standards such as QMS Ordinances No.169, ISO13485, and MDSAP audit requirements. - Organize and review processes, Quality Manual, Standard Operation Procedures, Working Instructions, QMS records, and other documents to assure regulatory compliances. - Evaluate necessity of action (CAPA, regulatory reporting and/or field action, improvement) from identified non-conformance, non-conformity and complaint. In addition, managing it. - Other improvements in QMS and Vigilance processes as MAH to adopt regulatory requirement, corporate polices and environmental change. - Participate in cross-functional team for new product introduction to provide expertise in quality and safety of Medical Devices, IVDs, and other products. Show More