Medline Hiring! Full Time QSR auditor in Federal Territory - Ricebowl

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.