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 process regulatory requirements.
Job requirements
education: industrial engineering, systems, electronics, or related field.
Experience: 2+ years in quality, preferably in the medical or electronics industry.
English: written and spoken 70%
technical knowledge:
iso 9001:2015, iso 13485, good documentation practices.
Quality tools (5 whys, ishikawa, pareto, fmea).
Internal and external audits.
Capa management and root cause analysis.
Skills:
effective communication.
Organization and attention to detail.
Teamwork and initiative leadership.
Management of document control systems (eqms, sharepoint, etc.).