Lead Auditor Medical Device

Empresaria Group PLC ·www.empresaria.com

Location Shah Alam, Selangor, Malaysia
Type Full time
Level Lead
Source Shazamme
Pharmaceutical Live
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Executive recruitment company, Monroe Consulting Malaysia is partnering with a leading global testing, inspection, and certification organization serving medical device and healthcare manufacturers worldwide. The organization provides testing, certification, and regulatory solutions to support product safety, quality, compliance, and international market access. The company is now looking to hire a Lead Auditor, Medical Device.

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.

Job 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

Frequently asked questions

Who is hiring for the Lead Auditor Medical Device role?
Empresaria Group PLC is hiring for the Lead Auditor Medical Device position, a Shazamme client. Apply directly on the employer's career site.
Where is the Lead Auditor Medical Device job located?
The Lead Auditor Medical Device role with Empresaria Group PLC is based in Shah Alam, MY.
Is the Lead Auditor Medical Device role full-time or contract?
This is a full time position at Empresaria Group PLC.
What experience level is the Lead Auditor Medical Device role?
The Lead Auditor Medical Device position is aimed at lead-level candidates.
How do I apply for the Lead Auditor Medical Device role at Empresaria Group PLC?
Apply directly on Empresaria Group PLC's career page via the Apply button on this listing. ZammeJobs links straight through to the employer's ATS — no third-party form, no resume database.
Apply direct