Lead Auditor Medical Devices

TÜV SÜD PSB Pte Ltd; Shah Alam; On-site; MYR 120,000 - 180,000; Full time

Job summary

TÜV SÜD Malaysia invites a Lead Auditor Medical Devices to plan, lead and deliver complex audits for medical device manufacturers across ASEAN, with a focus on Malaysia.

You will ensure regulatory compliance (ISO 13485, MDR/IVDR, MDSAP) and act as the technical lead for audits, coordinating with clients, authorities and internal teams to improve quality and safety across the region.

Qualifications

• Degree in engineering, life sciences, or related technical field.
• Several years of experience in the medical device QA/RA, manufacturing, R&D, or testing.
• Qualified ISO 13485 auditor; MDR/IVDR/MDSAP experience a plus.
• Proven experience leading audits or audit teams in international/regional contexts.
• Strong English communication and report-writing; regional languages are assets.
• Willingness to travel frequently within Malaysia and the ASEAN region.

Responsibilities

• Lead and conduct 3rd-party audits at medical device manufacturers in Malaysia and ASEAN.
• Assess QMS and technical 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 initiatives.
• Represent TÜV SÜD to authorities, clients and industry stakeholders in the region.

Skills

Audit leadership

ISO 13485

MDR/IVDR/MDSAP

English communication

Travel readiness

Analytical skills

International audits

Education

Engineering degree

Life sciences degree

Job description

TÜV SÜD - 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 is a leading global provider of technical services. More than 24,000 highly skilled employees across 1,000 offices around the globe pool their multidisciplinary expertise to partner clients in their business processes, enhancing their competitive strength and delivering tangible economic added value.

At TÜV SÜD we are passionate about technology. Innovations impact our daily lives in countless ways and we are dedicated to being part of that progress.

We test, we certify, we audit, 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.

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

TÜV SÜD – 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 is a leading global provider of technical services. More than 24,000 highly skilled employees across 1,000 offices around the globe pool their multidisciplinary expertise to partner clients in their business processes, enhancing their competitive strength and delivering tangible economic added value.

At TÜV SÜD we are passionate about technology. Innovations impact our daily lives in countless ways and we are dedicated to being part of that progress.

We test, we certify, we audit, 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.

#FUTUREINYOURHANDS

strive for professional excellence

have passion for technology

are keen to leave a mark

TÜV SÜD – 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 is a leading global provider of technical services. More than 24,000 highly skilled employees across 1,000 offices around the globe pool their multidisciplinary expertise to partner clients in their business processes, enhancing their competitive strength and delivering tangible economic added value.

At TÜV SÜD we are passionate about technology. Innovations impact our daily lives in countless ways and we are dedicated to being part of that progress.

We test, we certify, we audit, 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.