Lead Auditor Medical Devices

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