Commercial QA Lead - Medical Devices (Indonesia)

Monroe Consulting Group; Indonesia; On-site; IDR 600,000,000 - 900,000,000; Full time

Job summary

Monroe Consulting Group, an executive recruitment firm, is partnering with a leading organisation in the Healthcare industry to hire a Commercial Quality Assurance (QA) Manager - Indonesia.

Based in Indonesia, you will establish and maintain the Indonesia Commercial QMS, ensure MOH/BPOM regulatory compliance, lead audits and CAPA programs, and drive continuous quality improvements across commercial operations including post-market surveillance and complaint handling.

Qualifications

• Bachelor’s degree in Pharmacy, Science or a similar discipline recognised by authorities.
• Minimum 8 years’ QA experience in regulated healthcare industries.
• At least 3 years in Medical Device QA and QMS.
• ISO 13485:2016 Auditor certification is advantageous.
• Hands-on experience with QMS, audits, CAPA and regulatory compliance.

Responsibilities

• Establish, implement, and maintain the Indonesia QMS in line with MOH/BPOM and ISO 13485:2016.
• Serve as Penanggung Jawab Teknis (PJT) and ensure regulatory day-to-day compliance.
• Manage document control, training, quality metrics, audits, and CAPA processes.
• Lead MOH/BPOM inspections and external audits to ensure readiness.
• Support complaint handling, post-market surveillance, and third-party quality oversight.
• Drive continuous quality and process improvements with cross-functional teams.

Skills

Stakeholder management

Communication

Analytical thinking

Problem solving

Regulatory compliance

Auditing

Education

Bachelor's degree in Pharmacy/Science

Job description

Monroe Consulting Group, an executive recruitment firm, is partnering with a leading organisation in the Healthcare industry to hire a Commercial Quality Assurance (QA) Manager - Indonesia.

Based in Indonesia, you will establish and maintain the Indonesia Commercial QMS, ensure MOH/BPOM regulatory compliance, lead audits and CAPA programs, and drive continuous quality improvements across commercial operations including post-market surveillance and complaint handling.