QSR Auditor I

Job Summary

Job Description

JOB RESPONSIBILITIES

- 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..

- Draft and publish audit reports in high quality and timely

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

- 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..

a. Response to vendors’ questions;

b. Necessary instruction, guidance and training for suppliers;

c. Others

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

(a) Support to conduct pre audit

(b) Support to follow-up with vendors to address the problems identified during the audits

(c) Support vendor on CAPA review

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

Requirement

- Bachelor’s Degree.

- Willing to travel up to 50% of the time for business purposes (domestically and internationally).

- Fluent both in written and verbal English.

- Experience processing all relevant details, understanding and prioritizing their importance and drawing clear and concise conclusions.

Solid knowledge of ISO 13485, FDA regulations, QSR part 820, MDR 2017/745, ISO9001, ASTM standards and etc.

- Strong time management skills. Ability to manage multiple assignments.

- Good reporting and presentation skills

- Good communication and cooperation skills

- Familiar with general office software.

Based at Kuala Lumpur or Selangor.

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.