Lead Auditor Medical Devices

Tüv Süd Ag; Shah Alam, Kuala Lumpur; Hybrid; MYR 140,000 - 240,000; Full time

Job summary

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.

Qualifications

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

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 (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.

Skills

Audit leadership

Analytical skills

Communication skills

Report-writing skills

Education

Degree in engineering or life sciences

Job description

TÜV SÜD Group – A global leader in the field of testing, inspection, management system certification and product certification renowned for quality, integrity and technical excellence.

Established more than 150 years ago in Germany, TÜV SÜD Group is a leading global provider of technical services with more than 30,000 highly skilled employees across 1,000 offices worldwide. TÜV SÜD Group offers a wide range of testing & product certification, inspection, auditing & system certification, training and knowledge services. We are a premium quality, safety, and sustainability solutions provider.

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

We test, we audit, we inspect, we advise. We never stop challenging ourselves for the safety of society and its people. We breathe technology, we strive for professional excellence, and we leave a mark. We take the future into our hands. We are TÜV SÜD Group.

Work Area: Medical Devices & Healthcare

Country/Region: Malaysia

Working Model: Hybrid

Employment Type: Full time / regular

Company: TUV SUD (Malaysia) Sdn. Bhd.