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%
- 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.
- Effective communication.
- Organization and attention to detail.
- Teamwork and initiative leadership.
- Management of document control systems (eQMS, SharePoint, etc.).
