QA &RA Manager in a Medical device company

Implementation of a culture of quality Compliance with regulatory requirements and international standards, including ISO 13485, 21 CFR 820, EU-MDR 2017/745 - Preparation of annual quality plans in collaboration and oversight of their implementation (these plans may include initiatives for improving quality infrastructure, responding to new regulatory requirements/standards, etc.) - Management of the quality department: QC personnel and quality engineers - Professional guidance of all quality functions within the company, such as training, configuration management, supplier controls, incoming inspection, calibrations, customer complaints, CAPA, documentation controls etc. - Conducting quality training within the company - Leading quality audits (customer audits, regulatory bodies, and internal audits) - Leading management reviews - Defining quality goals and metrics in collaboration with management and defining improvement activities as needed.