Quality Engineer

We Are Hiring: QA Operations Engineer MESH Executive Solutions is proud to partner with a global pioneer in endovascular treatment and Class III medical device manufacturing to recruit a QA Operations Engineer for its Israeli site in Herzliya (hybrid work available). Position Overview The QA Operations Engineer will provide quality assurance support across the development, manufacturing, and release of Class III medical devices. The role includes maintaining and improving the Quality Management System (QMS), supporting compliance with applicable regulatory requirements, and collaborating with cross-functional teams to ensure product quality and patient safety. Responsibilities ·         Support the implementation, maintenance, and continuous improvement of the QMS in accordance with applicable FDA requirements, ISO 13485, EU MDR, and internal procedures. ·         Review and approve quality records related to nonconformances, MRB activities, deviations, change controls, CAPAs, and investigations, as applicable. ·         Conduct quality investigations, identify root causes, and support the implementation and effectiveness verification of corrective and preventive actions. ·         Review Device History Records (DHRs) and support product release activities. ·         Support internal and external audits, including Notified Body, FDA, supplier, and customer audits. ·         Monitor and analyze quality metrics to identify trends and drive improvements in product quality and operational efficiency. ·         Support supplier qualification, performance monitoring, and resolution of supplier quality issues. ·         Provide quality support for R&D, validation, and verification activities, including the review and approval of protocols and reports, as applicable. ·         Review and approve controlled documents in accordance with document control procedures. ·         Support risk management activities in accordance with ISO 14971. ·         Collaborate with Manufacturing, R&D, Supply Chain, and other functions to address quality issues and maintain compliance. ·         Support quality training and adherence to applicable procedures. ·         Perform additional QA activities as assigned by the QA Manager/Director. Qualifications ·         Bachelor’s degree in Engineering, Science, or a related field. ·         At least 3 years of QA experience in the Class III medical device industry. ·         In-depth knowledge of FDA quality system requirements, ISO 13485, ISO 14971, and EU MDR. ·         Experience conducting investigations, identifying root causes, and driving corrective actions. ·         Experience applying risk management methodologies and statistical tools. ·         Strong analytical and problem-solving skills, with excellent written and verbal communication abilities. ·         Auditor certification and experience with ERP/eQMS systems are advantages.