Lead Auditor Medical Device

Monroe Consulting Group; Malaysia; On-site; MYR 180,000 - 260,000; Full time

Job summary

Monroe Consulting Group, an Executive Recruitment firm, partners with an organisation in the Industrial sector to hire a Lead Auditor, Medical Device based in Malaysia. The Lead Auditor will lead complex audits for medical device manufacturers across ASEAN/ANZ, ensuring compliance with global regulatory and quality management standards.

Qualifications include a degree in engineering or life sciences, several years in the medical device industry, and ISO 13485 auditing qualification;

Qualifications

• Degree in engineering, life sciences, or related field.
• Several years of professional experience in the medical device industry (QA/RA, manufacturing, R&D, clinical, testing).
• ISO 13485 auditing qualification; MDR/IVDR and/or MDSAP experience is a strong advantage.
• Proven experience leading audits or audit teams, ideally in an international or regional context.

Responsibilities

• Lead and conduct 3rd-party audits for 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 organisation professionally towards authorities, clients, and industry stakeholders in the region.

Skills

Auditing leadership

Quality management systems assessment

Report writing in English

Analytical communication

Education

Degree in engineering, life sciences, or related field

Job description

Monroe Consulting Group, an Executive Recruitment firm, is partnering with an organisation in the Industrial industry to hire a Lead Auditor, Medical Device. This opportunity is based in Malaysia.

Position Overview

Lead and deliver complex audits for medical device manufacturers across ASEAN/ANZ, ensuring compliance with global regulatory and quality management standards.
Serve as a key technical authority, supporting clients and stakeholders while driving audit excellence and regulatory compliance across the region.

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 organisation professionally towards authorities, clients, and industry stakeholders in the region

Key Requirements

Qualifications & Experience

• 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

Technical / Functional Expertise

• Lead auditing experience within the medical device sector
• Assessment of quality management systems and technical documentation
• ISO 13485 auditing qualification
• Knowledge of MDR, IVDR and/or MDSAP
• Understanding of applicable local medical device regulations where relevant
• Strong report-writing capabilities in English

Soft Skills & Leadership Competencies

• 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
• Ability to act as a technical lead and escalation point for complex audits and key customers

• Willingness to travel frequently within Malaysia and the ASEAN region