Lead Auditor Medical Devices

TÜV SÜD; Kuala Lumpur; Hybrid; MYR 90,000 - 150,000; Full time

Job summary

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.

Responsibilities

• 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.

Skills

Analytical skills

Communication skills

Report-writing

English proficiency

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

Job Location: Kuala Lumpur, Shah Alam

Working Model : Hybrid

Employment Type: Full time / regular

Company: TUV SUD (Malaysia) Sdn. Bhd.

Org Unit Code

Requisition ID: 7335