MAIN PURPOSE OF ROLE

Summarize the main purpose of the role.

Analyze quality standards for components, materials or services.

Apply measures, sampling methods, testing methodology and other procedures that ensure that quality standards are met.

MAIN RESPONSIBILITIES

1. Apply quality principles, analyzes quality records, prepares reports and recommends improvements.

2. Conduct inspection, verification and validation of components or materials used in development processes.

3. Identify and address recurring problems either with the quality of the product or the reliability of testing procedures.

4. Document quality issues and performance measures for management review.

5. May liaise with external vendors.

6. Liaises with division and local teams to ensure that products meet the quality standards.

7. Perform /coordinate local sample test operation.

8. Support customer complaint handling locally.

9. Support internal audit in affiliates.

10. Support government inspection on-site.

QUALIFICATIONS

1. Bachelor’s or above degree is desirable in Life Sciences, Medical, Drug, Engineering or equivalent.

2. Preferably more 5+ years QA experience of post marketing or factory in global Drug or Medical Device.

3. Understand ISO13485 and/or ISO 9001, GMP system.

4. Person with ISO 13485 certificate is preferable.

5. Skill English with speak, listen, read and write.

6. Skill use on Word, Excel, PowerPoint etc.