Develop, implement, and maintain the Quality Management System in accordance with ISO 13485:2016, ISO 9001:2015, and local regulatory requirements (CPAKB).
Establish and review quality system standards, procedures, and documentation to ensure compliance with company and legal requirements.
Handle and coordinate international audit processes, including preparation of documentation, auditor liaison, and closing audit findings.
Coordinate communication and collaboration among departments to ensure effective QMS implementation.
Monitor quality KPIs and prepare regular reports for management.
Job Requirements
Minimum Bachelor Degree (S1) in Industrial Engineering, Quality Management, Electromedic, Biomedic, Electro or a related field.
Strong understanding of ISO 13485, ISO 9001, ISO 14971, and CPAKB requirements.
Knowledgeable in internal and external audits procedures, risk management, and documentation control
Highly detail-oriented, structured, and good in cross-department communication.
