Lead Medical Devices Auditor — ISO 13485 & MDR (Hybrid)

TÜV SÜD; Kuala Lumpur; Hybride; MYR 90 000 - 150 000; Plein temps

Résumé du poste

TÜV SÜD Group is a global leader in testing, inspection, certification and knowledge services. We seek a Lead Auditor Medical Devices to plan, lead and deliver audits across ASEAN/ANZ with focus on Malaysia.

You will assess quality management systems against ISO 13485, MDR/IVDR, and MDSAP, acting as the technical lead for clients and internal stakeholders. Willingness to travel within Malaysia and the region is required.

Qualifications

• Degree in engineering, life sciences, or related technical discipline.
• Several years of professional experience in medical device industry (QA/RA, manufacturing, R&D, clinical, testing).
• Qualified auditor for ISO 13485; MDR/IVDR/MDSAP experience is a strong advantage.
• Proven experience leading audits or audit teams in international or regional context.
• Fluent in English; additional regional languages are a plus.

Responsabilités

• Lead and conduct third-party audits at medical device manufacturers in Malaysia and ASEAN.
• Assess quality management systems and documentation against ISO 13485, MDR/IVDR, MDSAP, and local regs.
• Prepare high-quality documentation and follow up on client requests.
• Act as technical lead and escalation point for complex audits and key customers.
• Contribute to internal procedures and continuous improvement.
• Represent TÜV SÜD professionally to authorities, clients, and stakeholders.

Connaissances

Analytical skills

Communication skills

Report-writing

English proficiency

Formation

Degree in engineering or life sciences

Description du poste

TÜV SÜD Group is a global leader in testing, inspection, certification and knowledge services. We seek a Lead Auditor Medical Devices to plan, lead and deliver audits across ASEAN/ANZ with focus on Malaysia.

You will assess quality management systems against ISO 13485, MDR/IVDR, and MDSAP, acting as the technical lead for clients and internal stakeholders. Willingness to travel within Malaysia and the region is required.