QSR auditor

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 ManagerRequirement- 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.