Lead Auditor, Medical Devices (ISO 13485 & MDR) – Hybrid

Tüv Süd Ag; Shah Alam, Kuala Lumpur; Hybrid; MYR 140.000 - 240.000; Vollzeit

Zusammenfassung

TÜV SÜD Group is seeking a Lead Auditor Medical Devices to plan, lead and deliver complex audits at medical device manufacturers across ASEAN/ANZ, focusing on Malaysia. You will ensure regulatory compliance with ISO 13485, MDR, IVDR and MDSAP, and serve as a technical contact for clients and internal stakeholders.

You will lead audits, assess QMS, prepare documentation, and collaborate with authorities and customers while traveling frequently within Malaysia and the ASEAN region.

Qualifikationen

• Qualified auditor for ISO 13485; MDR/IVDR/MDSAP experience is a strong advantage.
• Strong analytical, communication, and report-writing skills in English.

Aufgaben

• 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 (ISO 13485, MDR, IVDR, MDSAP).
• Prepare high-quality documentation and 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.

Kenntnisse

Audit leadership

Analytical skills

Communication skills

Report-writing skills

Ausbildung

Degree in engineering or life sciences

Jobbeschreibung

TÜV SÜD Group is seeking a Lead Auditor Medical Devices to plan, lead and deliver complex audits at medical device manufacturers across ASEAN/ANZ, focusing on Malaysia. You will ensure regulatory compliance with ISO 13485, MDR, IVDR and MDSAP, and serve as a technical contact for clients and internal stakeholders.

You will lead audits, assess QMS, prepare documentation, and collaborate with authorities and customers while traveling frequently within Malaysia and the ASEAN region.