QA Specialist
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Summary
Ensures medical-device quality and regulatory compliance by auditing processes, documents, and non-conformances against ISO13485, MDSAP, and QMS Ordinances No.169 in Tokyo.
- 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.