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Quality System Engineer

Shenzhen, Guangdong Province, China

Job Type

Full Time

About the Role

1.Develop, maintain, and manage the quality management system for medical device research and development.
2.Prepare and conduct external audits, organize the development of corrective and preventive measures, and track and verify their implementation.
3.Ensure the integrity and control of documentation and records related to the research and development and transfer of medical device products.
4.Implement and enforce the research and development system and manage document control.
5.Organize daily internal audits and inspections, assist in handling registration-related matters, and support quality system work in collaboration with relevant colleagues and departments.
6.Assist in completing other tasks assigned by superiors in a timely and accurate manner.


  1. Bachelor's degree or above.

  2. Minimum of 2 years of work experience, preferably in quality management in the medical industry.

  3. Familiarity with GMP/ISO13485 and other quality management systems, with at least 2 years of experience in system-related work.

  4. Excellent communication and presentation skills.

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