Key respoibility:

1.To implement and control the quality of incoming material, in-process and finished products, guarantee the quality of products delivered according to customer requirements.

2.To be respoible for medical facility and eure the production and all process comply with FDA’s regulation.

3.To generate the ipection criteria or ipection specification

4.To solve the quality problems happened in the whole process of product realization.

5.To work cooperatively with team membe to set up the quality system, and make the system to meet the requirements of ISO13485.

6.Eure the supplier’s product and process match the SMC quality request.

7.To implement and maintain procedures and documentation required of an effective Quality Management System;

8.Work with USA quality department and eure QA policies and procedures in line with USA procedures.

9.Organizing other departments to push supplier to improve their QA system and the quality of their products.

Key requirements:

1.Bachelor degree or above and major of science and engineering.

2.Relevant practical experience and a progressive career in Quality, preferably in the medical device industry.

3.Working knowledge of ISO9001:2000, preferably of ISO13485.

4.Owning the qualification of internal auditor of ISO13485:2003.

5.Has FDA audit leading experience.

6.Competent in all quality tools such as SPC, DOE, FMEA etc.