Supplier Quality Assurance Auditor

JOB SUMMARY :

Under direct supervision, audit Medline suppliers’ quality management system per applicable regulations

CORE JOB RESPONSIBILITIES :

1) Audit Medline Asia suppliers per Medline internal audit SOP and applicable regulations as ISO 13485, FDA regulations, QSR part 820, MDR 2017 / 745, ISO9001, ASTM standards and etc.

2) Prepare Audit reports post audit as a part of Audit Compliance & also perform pre- assessment audit support. Draft and publish audit reports in high quality and timely.

3) Conduct adequate CAPA follow-up and evidence review for supplier in a timely manner

4) Provide supports and guidance for vendors in improving the quality management system per Medline internal audit SOP and applicable regulations as ISO 13485, FDA regulations, QSR part 820, MDR 2017 / 745, ISO9001, ASTM standards and etc..

• Response to vendors’ questions;
• Necessary instruction, guidance and training for suppliers;
• Others

5) Support pre audit and support vendors on 3rd party audit project assigned by supervisor / manager

6) Other assignments related to Quality Management System, supplier audit or assigned by Manager

EDUCATION :

Pharmacy / M. Pharmacy, Life science background, B.Tech / M.Tech. M Pharma OR Biotech / Bio Medical Engineering.

CERTIFICATION :

BSI (or equivalent) ISO 13485 : 2016 certification.

RELEVANT WORK EXPERIENCE

ADDITIONAL :