QSR Auditor I

Job Responsibilities

• Audit Medline Asia suppliers according to Medline internal audit SOP and applicable regulations (ISO 13485, FDA regulations, QSR part 820, MDR 2017/745, ISO 9001, ASTM standards, etc.).
• Draft and publish high‑quality audit reports in a timely manner.
• Conduct CAPA follow‑up and review evidence for suppliers promptly.
• Provide support and guidance to vendors for improving their quality management systems per Medline internal audit SOP and applicable regulations.
• Respond to vendor questions and provide training, instruction, and guidance to suppliers.
• Support pre‑audit activities and 3rd‑party audit projects assigned by the supervisor/manager.
• Follow up with vendors to address problems identified during audits and support them on CAPA reviews.
• Handle additional assignments related to the Quality Management System, supplier audit, or other related responsibilities as assigned by ...