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Job Description
Develop and maintain a robust quality system to ensure regulatory compliance and continuous improvement.
1. Coordinate documentation management to ensure the efficiency of the quality system.
Conduct regulatory intelligence to monitor and act on relevant laws and standards.
Manage quality control functions and operational permissions of computer information systems.
1. Review and dynamically manage the qualifications of medical device suppliers, products, and purchasers.
Confirm and supervise the handling of non-conforming medical devices.
1. Coordinate the verification and calibration of relevant facilities and equipment.
Implement UDI to ensure medical device traceability.
Investigate, handle, and report medical device quality complaints and incidents.
1. Manage medical device recalls and quality safety risk consultation...