Lead Auditor - Medical Devices

TÜV SÜD; Kuala Lumpur; Hybrid; MYR 90,000 - 130,000; Full time

Job summary

TÜV SÜD Group in Malaysia is actively seeking a Lead Auditor for Medical Devices to plan, lead, and deliver complex audits at manufacturers across ASEAN, with a primary focus on Malaysia. You will ensure compliance with ISO 13485 andMedical device regulations, acting as the technical lead for clients and internal teams.

The role requires a degree in engineering or life sciences, substantial audit leadership experience, strong English communication, and willingness to travel frequently within

Qualifications

• Degree in engineering, life sciences, or related technical discipline.
• Several years of professional experience in the medical device industry (QA/RA, manufacturing, R&D, clinical, testing).
• Qualified auditor for ISO 13485; MDR/IVDR/MDSAP experience is a strong advantage.

Responsibilities

• Lead and conduct 3rd-party audits at medical device manufacturers in Malaysia and the ASEAN region.
• Assess quality management systems and technical documentation against ISO 13485, MDR/IVDR, MDSAP and local regulations.
• Prepare high-quality documentation and follow up on client requests in a timely manner.
• Act as technical lead and escalation point for complex audits and key customers.
• Contribute to internal procedures and continuous improvement initiatives.

Skills

Audit leadership

English proficiency

Analytical skills

Communication

Education

Degree in engineering or life sciences

Tools

ISO 13485 auditing

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

Job Location: Shah Alam, Kuala Lumpur

Working Model : Hybrid

Employment Type: Full time / regular

Company: TUV SUD (Thailand) Ltd.

Org Unit Code: MHS-DIV

Requisition ID: 8442