- Responsible for the maintenance and improvement of the document control system, and also responsible for contacting the relevant personnel at global for management of electronic document control system.

• Responsible for the maintenance and improvement of the change control system within the quality management system.
• Assist QA manager to continuously improve the quality management system according to the requirements of the new/updated regulations and company requirements. Regularly organize and statistically analyze the quality data in the operation of the quality system.
• Organize and coordinate the development and implementation of the company's GMP training program.
• Assist QA manager to develop internal audit plan and coordinate internal audit of quality management system.
• Assist QA managers in following up quality objectives achievement, organizing management reviews, and regularly analyzing and following up issues.
• Organizing the reviewing and root cause analysis of nonconformity, develops corrective and preventive actions, and supervises the implementation of corrective and preventive actions.
• Follow up government work related to the quality management system, including sampling and inspection, licensing matters, annual reports, etc.
• Organizing and coordinating the work of external audits.
• Assist and participate in other quality management tasks assigned.

Position Requirements

- Bachelor degree and above. Major in Chemistry, Pharmaceuticals, Biology, Biochemistry, Medical Devices related etc.

• Proficiency in Office software, including Outlook, WORD, EXCEL, Power Point, etc.
• Familiar with the laws and regulations of medical device supervision and management. Familiar with ISO13485 standards, risk management of medical devices (ISO 14971) etc., CE and FDA experience is preferred.
• At least 3 years working experience in the quality management system of the medical device industry, with certain management experience.

Personal Requirements

Careful.