Responsibility:
1.Be responsible for communication with RB Group Quality Top Management for product quality and quality management system.
2.Report product quality performance issue including either quality problem or achievement to RB Group Quality Top Management and be responsible for providing CAPA for any quality issue if required to ensure the product quality are protected.
3.Be responsible for implement RB quality policy to ensure both product quality and quality management system are implemented successfully.
4.Overall responsibility for the implementation and maintenance of the quality management system in accordance with ISO 9001 and ISO 13485.
5.Overseas the release of raw materials, in-process goods, and final product which comply with company standards.
6.Assumes overall responsibility for the corrective action and preventive action programs to drive continuous improvement in order to improve quality, safety, and reduce cost.
7.Manages the handling of customer complaints according to site and Group requirements.
8.Assists the company’s regulatory affairs to ensure compliance in domestic and international markets.
9.Responsible for adverse incident reporting of medical devices according to company procedure.
10.Holds monthly communication meetings to ensure QA/QC staff is updated timely in regard to company policies and procedures.

Qualification:
1.BS degree or equivalent。
2.At least 5 years quality experience in a manufacturing and quality environment.
3.Able to communicate effectively in English。
4.Experienced regarding ISO9001 and ISO13485.
5.Regulatory experience regarding medical devices in domestic and international markets.

其他信息

行业要求：全部行业