Quality Assurance (QA) Manager

As the Quality Assurance (QA) Manager, you will be responsible for leading and managing the overall quality system within our medical device manufacturing environment. Your main role is to ensure that all production, product development, and distribution processes comply with national and international quality standards and regulatory requirements.

• Design, implement, and maintain a Quality Management System (QMS) in compliance with ISO 13485, GMP, and relevant Indonesian medical device regulations.

• Lead internal and external audits, including certification audits and inspections by regulatory authorities.

• Oversee document control activities, including the development and revision of SOPs, Work Instructions, and quality records.

• Manage and resolve deviations, product complaints, non-conformities, and drive effective CAPA and Root Cause Analysis (RCA) processes.

• Collaborate closely with cross-functional departments such as Production, QC, Regulatory Affairs, and R&D to ensure end-to-end product quality.

• Ensure regular quality training and awareness programs are conducted for all relevant personnel.

• Prepare quality reports and conduct management review meetings to drive continuous improvement.

• Support and ensure compliance during medical device registration and regulatory submissions.

Information :

• Company : Oneject Indonesia
• Position : Quality Assurance (QA) Manager
• Location : Bekasi
• Country : ID