Medical Device Lead Auditor

Lead Auditor Medical Device

As Lead Auditor Medical Devices, you are responsible for planning, leading, and delivering complex audits at medical device manufacturers across ASEAN/ANZ, with a focus on Malaysia. You ensure compliance with regulatory and standards requirements (e.g. ISO 13485, MDR, IVDR, MDSAP) and act as a key technical contact for both clients and internal stakeholders.

Key Responsibilities

• Lead and conduct 3rd-party audits at medical device manufacturers in Malaysia and the wider ASEAN region
• Assess quality management systems and technical documentation against applicable standards and regulations (e.g. ISO 13485, MDR, IVDR, MDSAP, local regulations where applicable)
• Prepare high-quality documentation timely follow-up on client requests.
• Act as technical lead and escalation point for complex audits and key customers
• Contribute to internal procedures, best practices, and continuous improvement initiatives
• Represent the organization professionally towards authorities, clients, and industry stakeholders in the region

Job Requirements

• Degree in engineering, life sciences, or a related technical/natural science discipline
• Several years of professional experience in the medical device industry (e.g. QA/RA, manufacturing, R&D, clinical, testing)
• Qualified auditor for ISO 13485 experience with MDR / IVDR and/or MDSAP is a strong advantage
• Proven experience in leading audits or audit teams, ideally in an international or regional context
• Strong analytical, communication, and report-writing skills in English additional regional languages are an asset
• High level of customer orientation and ability to manage challenging audit situations
• Willingness to travel frequently within Malaysia and the ASEAN region