Company Background  Our client is a U.S. medical technology company, serving healthcare institutions, life science researchers, clinical laboratories, industry and the general public. Our client manufactures and sells a broad range of medical supplies, devices, laboratory equipment and diagnostic products, with offices in nearly 50 countries worldwide.

Responsibility:

1. Develop quality control document for new products/processes of manufacturing..

2. Handle non-conforming issues properly.

3. Handle daily quality issues of material or in-process.

4. Responsible for internal quality system audit and supplier audit.

5. Responsible for customer complaint investigation.

6. Issue and follow up CAPA.

7. Review daily batch record and product release.

8. Assist with the quality system setting up and consistent improvement.

9. Collect quality data and do analysis periodically.

10. Performs any other task(s) as assigned

Desire:

1.      Bachelor degree, majoring in Biological, medical, quality management related field.

2.      At least 3 years experience in quality assurance areas under ISO13485.

3.      Multinational company experience is a plus.

4.      Hands on computer skills, especially strong skills in MS Excel and Access.

5.      Certified QMS internal audit for ISO9001 or ISO13485.

6.      Familiar with China GMP.

7.      Familiar with quality tools SPC.

8.      Six Sigma knowledge preferable.

9.      Quality engineer license preferable.

10.   Good command of English and Mandarin both verbal and writing.

11.   Self-motivated, initiative and able to work under pressure.

12.   Good interpersonal skill.