Ensure the implementation, maintenance, and continuous improvement of the Quality Management System in accordance with international standards (ISO 9001, ISO 13485, etc.), internal policies, and applicable regulatory requirements. Act as a liaison between operational areas and the quality system to ensure compliance and system effectiveness.
Main Responsibilities
Manage and maintain QMS documentation (quality manual, procedures, work instructions, formats).
Coordinate internal and external audits (certification, customer, regulatory).
Follow up on corrective and preventive actions (CAPA), ensuring effective and timely closure.
Monitor key quality indicators such as audit findings, CAPA closure time, etc.
Participate in management reviews and risk analysis of the system.
Train new hired personnel on topics related to the QMS and quality policy.
Support document change management and version control.
Ensure compliance with applicable product and proces...