Commercial QA Manager (Medical Devices)

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. This opportunity is based in Indonesia.

Position Overview

This role is responsible for establishing, implementing, and maintaining the Indonesia Commercial Quality Management System (QMS) in compliance with local medical device regulations and global quality standards.
The position plays a critical role in ensuring regulatory compliance, audit readiness, and continuous quality improvement across commercial operations.

Key Responsibilities

• Establish, implement, and maintain the Indonesia Commercial Quality Management System (QMS) in alignment with local regulatory requirements and global quality standards.
• Serve as Penanggung Jawab Teknis (PJT) and ensure day-to-day compliance with applicable MOH/BPOM requirements.
• Manage key QMS activities including document control, training, quality metrics, management review, and internal/external audits.
• Ensure compliance with CDAKB, ISO 13485:2016, and other applicable medical device quality and regulatory requirements.
• Lead and coordinate MOH/BPOM inspections and external audits, ensuring continuous audit readiness.
• Manage non-conformance investigations and Corrective and Preventive Actions (CAPA).
• Support complaint handling, post-market surveillance, and third-party quality oversight.
• Monitor regulatory and quality-related changes in Indonesia and assess their potential impact on business operations.
• Partner with regional and local cross-functional teams to identify opportunities for continuous quality and process improvement.
• Provide Quality Assurance support for business expansion, new facilities/sites, and other assigned projects.

Key Requirements

Qualifications & Experience

• Bachelor's degree in Pharmacy, Science, or another scientific discipline recognised by the relevant authorities, with eligibility to serve as PJT.
• Minimum 8 years of Quality Assurance experience within regulated healthcare industries.
• At least 3 years of experience in Medical Device Quality Assurance.
• ISO 13485:2016 Auditor certification would be an advantage.
• Hands-on experience in QMS implementation and maintenance, audits, CAPA, and regulatory compliance.

Technical / Functional Expertise

• Strong understanding of MOH/BPOM regulations, CDAKB, and ISO 13485:2016.
• Expertise in Quality Management Systems (QMS), audit management, regulatory inspections, and compliance programmes.
• Experience in managing non-conformance investigations, corrective and preventive actions, complaint handling, post-market surveillance and third-party quality oversight.
• Ability to assess regulatory changes and their impact on business operations.
• Experience supporting quality activities related to business expansion and new facilities/sites.

Soft Skills & Leadership Competencies

• Strong stakeholder management and communication skills, with the ability to collaborate effectively across local and regional teams.
• Comfortable working independently in a fast-paced and evolving business environment.
• Strong analytical and problem-solving capabilities with the ability to develop practical, well-considered solutions.
• Demonstrated ability to drive continuous improvement initiatives and partner effectively with cross-functional stakeholders.