QSR Auditor II

Job Summary

Job Description

1.    Perform QMS audit to vendors within scope of medical device, drug product, cosmetic product and lab, write audit report, and follow-up supplier CAPA.

2.    Work as project leader in Vendor FDA project, supervise vendor to adequately establish and maintain QMS based on 21CFR820 or 21CFR210&211, and support vendor for FDA audit, act as consultant to help vendor establish a better QMS with professional suggestions.

3.    Monitor vendors’ quality management system with proper visiting in key vendor FDA projects, identify their QMS problems under regular review.

4.    Provide QMS support for new vendor set up project cover drug, cosmetic and lab, support corporation GSO project.

5.    Provide necessary QMS training to vendor.

6.    Deal with 510k cases, independently handle 510k case under full communication with buyer/QA and suppliers timely.

7.    Complete assigned RA case like design control, process validations within timeline under good cooperation with QAs and other stakeholders.

8.    Support team on internal audit and CAPA follow up if needed.

9. Other tasks assigned by supervisor, like change control, Kaizen projects, etc.

About Medine:
Medline is a leading global healthcare company providing quality medical and surgical supplies with superior value throughout North and South America, Europe, Asia and the Middle East. Our ability to create new products, produce less waste and deliver solutions our customers need quickly and cost-effectively is what sets us apart.
Founded in 1910, Medline has grown from a small manufacturer of surgical gowns and uniforms to a thriving global healthcare company driven by an entrepreneurial spirit and strong commitment to its customers. Fifty-four years of consecutive annual growth have led to 2021 sales of more than $20.2 billion worldwide and a stream of new products and services. Medline holds top-tier market share in more than a dozen major medical product categories around the world.

About Medline GSO:
We are Global Sourcing Organization. We provide global procurement, quality assurance, supply chain, marketing and trade compliance services for Medline.

We're 500+ dedicated healthcare professionals across Asia and Latin America. Our focus is on building a robust and sustainable global supply chain to help strengthen Medline's position as a leading provider of healthcare products and services.
Our goal is to deliver the best pricing, quality, availability and innovation through collaboration with our 25+ product divisions, R&D, quality and operations, as well as with our 500+ suppliers across the globe.