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.).