LEAD AUDITOR (MEDICAL DEVICE)

ARG INTERNATIONAL CERTIFICATION SDN BHD; Rawang; On-site; MYR 100,000 - 167,000; Full time

Job summary

ARG INTERNATIONAL CERTIFICATION SDN BHD is seeking an experienced Lead Auditor to plan, coordinate, and execute ISO-based certification, surveillance, and recertification audits in Rawang, Selangor. You will verify client applications, develop audit plans, allocate tasks, and ensure audit objectives are met with impartiality.

Ideal candidates hold a degree in a relevant field, be a certified lead auditor for ISO 9001/13485, and bring 4+ years of professional experience including audit team

Qualifications

• Degree in Engineering, Science, Quality Management, or related discipline.
• Certified Lead Auditor in ISO 9001, ISO 13485, or relevant standard.
• Minimum 4 years of professional experience, including at least 2 years as an auditor.
• Proven leadership in conducting audits independently and managing audit teams.
• Strong knowledge of audit principles, ISO standards, and regulatory requirements.
• High level of objectivity, impartiality, and professional ethics.
• Excellent communication, organizational, and report-writing skills.
• Medical Device Auditor must meet the requirements set in MDA/GD/0023

Responsibilities

• Lead the planning, coordination, and execution of certification, surveillance, and recertification audits.
• Review and verify client application details, scope, MDTA classification, and relevant documentation prior to audit.
• Develop audit plans, allocate responsibilities to team members, and ensure audit objectives are met.
• Conduct opening and closing meetings with the client, clearly communicating audit scope, process, and results.
• Supervise audit team activities to ensure consistency, completeness, and compliance with audit protocols.
• Evaluate and classify audit findings, determine conformity status, and ensure proper documentation of nonconformities.
• Compile, finalize, and submit complete audit reports, including recommendations, to the Client Manager.
• Ensure that audit activities are conducted impartially and in line with ISO/IEC 17021-1 and internal SOPs.
• Guide and mentor junior auditors during audits and provide on-the-job feedback.
• Communicate with the Client Manager on any issues affecting the audit schedule or outcome.
• Coordinate with Technical Support or Admin teams to ensure proper documentation and logistics.
• Participate in internal calibration, peer reviews, and audit performance evaluations.
• Stay updated on changes to standards and certification requirements and apply them during audits.

Skills

Auditing

Leadership

Documentation

Communication

Regulatory knowledge

Ethics

Report writing

Client coordination

Education

Degree in Engineering, Science, Quality Management, or related discipline

Tools

ISO 9001

ISO 13485

ISO 17021-1

Job description

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ARG INTERNATIONAL CERTIFICATION SDN BHD – Rawang, Selangor

1. Lead the planning, coordination, and execution of certification, surveillance, and recertification audits.
2. Review and verify client application details, scope, MDTA classification, and relevant documentation prior to audit.
3. Develop audit plans, allocate responsibilities to team members, and ensure audit objectives are met.
4. Conduct opening and closing meetings with the client, clearly communicating audit scope, process, and results.
5. Supervise audit team activities to ensure consistency, completeness, and compliance with audit protocols.
6. Evaluate and classify audit findings, determine conformity status, and ensure proper documentation of nonconformities.
7. Compile, finalize, and submit complete audit reports, including recommendations, to the Client Manager.
8. Ensure that audit activities are conducted impartially and in line with ISO/IEC 17021-1 and internal SOPs.
9. Guide and mentor junior auditors during audits and provide on-the-job feedback.
10. Communicate with the Client Manager on any issues affecting the audit schedule or outcome.
11. Coordinate with Technical Support or Admin teams to ensure proper documentation and logistics.
12. Participate in internal calibration, peer reviews, and audit performance evaluations.
13. Stay updated on changes to standards and certification requirements and apply them during audits.

QUALIFICATIONS AND REQUIREMENTS

1. Degree in Engineering, Science, Quality Management, or related discipline.
2. Certified Lead Auditor in ISO 9001, ISO 13485, or relevant standard.
3. Minimum 4 years of professional experience, including at least 2 years as an auditor.
4. Proven leadership in conducting audits independently and managing audit teams.
5. Strong knowledge of audit principles, ISO standards, and regulatory requirements.
6. High level of objectivity, impartiality, and professional ethics.
7. Excellent communication, organizational, and report-writing skills.
8. Medical Device Auditor must meet the requirements set in MDA/GD/0023