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.
Requirements:
Engineering or science academic degree Certified Quality Engineer (ICQE/CQE, with preference for certification from the American Society for Quality) Minimum of 5 years of experience in QA&RA management of medical device Certified Medical device lead auditor (advantage)
Engineering or science academic degree Certified Quality Engineer (ICQE/CQE, with preference for certification from the American Society for Quality) Minimum of 5 years of experience in QA&RA management of medical device Certified Medical device lead auditor (advantage)
This position is open to all candidates.
