JOB RESPONSIBILITIES:

1. Interface with Medline internal groups such as corporate QA, sourcing team etc.

2. Travel to the supplier sites and conduct on-site quality audits.

3. CAPA Follow-up with the suppliers to address the problems identified during the audits.

4. Publish audit reports in a timely manner.

QUALIFICATIONS

1. Excellent verbal and written English

2. Strong time management skill

3. Strong communication skills.

4. Ability to travel extensively (60%).

5. Good interpersonal and organization skills.

6. Working knowledge of MS office is required.

7. At least 3 years working experience in medical device or the relevant industries.

8. Bachelor degree and major in Chemicals, Microbiology, Engineering etc. is preferred

9. Extensive knowledge and experience with auditing against FDA QSR/ISO13485 for medical devices and FDA 210, 211 for pharmaceuticals

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