About this role
<p>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.</p> <h1>Main Responsibilities</h1> <ul> <li>Manage and maintain QMS documentation (quality manual, procedures, work instructions, formats).</li> <li>Coordinate internal and external audits (certification, customer, regulatory).</li> <li>Follow up on corrective and preventive actions (CAPA), ensuring effective and timely closure.</li> <li>Monitor key quality indicators such as audit findings, CAPA closure time, etc.</li> <li>Participate in management reviews and risk analysis of the system.</li> <li>Train new hired personnel on topics related to the QMS and quality policy.</li> <li>Support document change management and version control.</li> <li>Ensure compliance with applicable product and process regulatory requirements.</li> </ul> <h1>Job Requirements</h1> <ul> <li>Education: Industrial Engineering, Systems, Electronics, or related field.</li> <li>Experience: 2+ years in quality, preferably in the medical or electronics industry.</li> <li>English: Written and spoken 70%</li> </ul> <ul> <li><strong>Technical Knowledge:</strong></li> </ul> <ul> <li>ISO 9001:2015, ISO 13485, good documentation practices.</li> <li>Quality tools (5 Whys, Ishikawa, Pareto, FMEA).</li> <li>Internal and external audits.</li> <li>CAPA management and root cause analysis.</li> </ul> <ul> <li><strong>Skills:</strong></li> </ul> <ul> <li>Effective communication.</li> <li>Organization and attention to detail.</li> <li>Teamwork and initiative leadership.</li> <li>Management of document control systems (eQMS, SharePoint, etc.).</li> </ul>