Responsibilities:

1. Organize and improve the medical device quality management system and monitor it  to ensure its effective operation;

2. Supervise and inspect the documents management of the company's quality management system and the inspection of key manufacuring processes, review and check the original records;

3.Responsible for review and evaluation the records of batch production ;

4. Organize and manage quality management activities such as deviating investigation and changing control according to management and operation procedures;

5. Responsible for self-inspection of the company's quality system, making self-inspection plans, coordinating the establishment of self-inspection teams and completing self-inspection work and reports;

6. Participate in the analysis and review of department nonconformities, and organize the implementation of corrective and preventive measures; '

7. Supervise the implementation of corrective and preventive measures on production site and report to superior in time.

8. Responsible for the quality process control on the production site, and standardize the operation of retention sample and sampling.

Requirements:

1.Familiar with medical device quality management system, such as ISO13485 management system, sterile medical device

Production quality management standard. Medical device production quality management standard (implant) is preferred, medical device internal auditor certificate is preferred;

2. Organized or participated in the daily management of medical device quality management system. Having participated in the audit of provincial bureau or above regulatory bodies is preferred;

3. Major in biological science, Medical device, Clinical Medicine, material science, Laboratory science, etc.

Working Experience:

At least 1 year experience as aseptic medical device QA engineer

Comprehensive ability: 

Strong sense of responsibility, communication and coordination ability, analysing and problem-solving ability with team work ability.

Well paid,benefits negotiable for top talents.