Quality Manager
CurrentOperating the Quality Management System in line with standards and regulations.Monitoring and evaluating the in-house QMS performance.Planning, implementing, and following up on internal audits.Organizing and following up on external audits.Detecting nonconformities and managing CAPA and improvement activities.Identifying workflows.Developing and improving processes.Ensuring employees comply with QMS policies.Organizing internal and external QMS trainings.Monitoring departmental performances.Integrating company applications with the QMS.Implementing the QMS per ISO 13485 and ISO 9001 standards.Preparing, controlling, and monitoring technical files according to EU 2017/745 MDR.Planning and organizing Risk Management processes.Organizing verification and testing activities.Conducting Clinical Evaluation activities.Planning and following up on post-market clinical follow-up and surveillance activities.Managing FDA registrations.
