Quality System Leadership Maintain and continuously improve the Quality Management System (QMS) in accordance with ISO 13485:2016 and MDR requirements. Assist internal and external quality audits, including Notified Body inspections and supplier audits. Ensure alignment of QMS documentation with MDR Annex IX and Annex XI requirements. Oversee CAPA, non-conformance, and change control processes to ensure timely resolution and compliance. Regulatory Compliance Ensure product and process compliance with EU MDR 2017/745, including Technical Documentation, Post-Market Surveillance (PMS), and Vigilance. Collaborate with Regulatory Affairs to support Notified Body submissions, renewals, and responses. Monitor regulatory changes and proactively implement updates to the QMS and product documentation. Product Quality Oversight Support complaint handling, root cause analysis, and trending for continuous improvement. Qualifications Bachelor’s or Master’s degree in engineering, life sciences, or quality management. Minimum 5 years of experience in QA roles within the medical device industry. Proven expertise in ISO 13485:2016, EU MDR 2017/745, and applicable standards (e.G., ISO 14971, IEC 62304). Experience with Class IIa/IIb or Class III devices and Notified Body interactions. Strong leadership, project management, and communication skills. Proficiency in QMS software and document control systems