Commercial QA Manager

Monroe Consulting is partnering with a global medical device company to recruit a Commercial Quality Assurance (QA) Manager – Indonesia. This position will play a key role in establishing, implementing, and maintaining the Quality Management System (QMS) for the Indonesia commercial operations, ensuring compliance with local medical device regulations and global quality standards.

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.

Requirements

• Bachelor's degree in Pharmacy, Science, or another scientific discipline recognized 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.
• Strong understanding of MOH/BPOM regulations, CDAKB, and ISO 13485:2016.
• ISO 13485:2016 Auditor certification would be an advantage.
• Hands-on experience in QMS implementation and maintenance, audits, CAPA, and regulatory compliance.
• 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.