Quality Management System

Job description :

• 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.

Qualification :

• Minimum Bachelor's 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.
• Familiar with manufacturing processes, QC activities, and technical documentation.
• Highly detail-oriented, structured, and good in cross-department communication.