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.
Job details are sourced from the employer's original posting.
