Manage the preparation/revision, approval, effectiveness, issuance, and recycling of quality management system documents, as well as their specific implementation in operations.
Ensure the effective operation of the documented quality management system through mechanisms such as management review, internal audit, change control, CAPA to ensure reliability and withstand supervision and inspection from regulatory departments and second/third-party audits.
Maintain close contact with regulatory authorities, submit required reports promptly, and organize relevant personnel to participate in designated training and assessments.
Organize activities for software verification/confirmation of the quality management system implementation.
Job Requirements
Bachelor's degree or above in mechanical engineering, electronics engineering, electrical engineering medical field or related disciplines with at least 3 years of working experience.
Proficient knowledge of quality management system standards (YY/T 0287,GMP) with practical application skills.
