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-Mandatory.
Certified Medical device lead auditor (advantage)
This position is open to all candidates.
