Medical Device ISO13485 auditor(homebased)

Overview

Medical Device ISO13485 auditor assessor (homebased) – BSI WP. Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia

Responsibilities

• As a Medical Device Auditor, you’ll travel to medical device manufacturers across APAC to assess their ISO 13485 quality management system, ensuring patient safety and regulatory compliance.
• During the first six months, you’ll receive training in ISO 13485 Lead Auditor training, MDSAP (Medical Device Single Audit Programme), and MDR (Medical Device Regulation).
• Initially observe how audits are conducted, then perform audits on an individual basis on site at medical device manufacturers across APAC and remotely from your home office.
• In a typical week after full training, conduct audits on site or remotely, write up reports, and liaise with the planning team to manage your audit schedule.
• Continue your MDR development and be an advocate for the ISO 13485 APAC Delivery Tea...