Job requirements and application form

This role is responsible for ensuring compliance, quality, and operational excellence throughout the development and manufacturing of Class III medical devices. Responsibilities • Lead, mentor, and manage the QA team, including task prioritization and performance development • Maintain and continuously improve the Quality Management System in compliance with ISO 13485, EU MDR, and FDA QSR (21 CFR 820) • Support Operations activities, including manufacturing, validation, MRB, CAPA, and supplier quality • Oversee CAPA, nonconformances, deviations, complaints, risk management, document control, and training processes • Prepare, implement, and maintain quality plans and annual quality activities • Actively participate in and support internal, supplier, and regulatory audits, including preparation, execution, and follow-up • Support regulatory submissions and interactions as required • Ensure quality oversight of QMS modules • Collaborate cross-functionally with R&D, Regulatory Affairs, Operations, and Clinical teams • Promote a strong culture of quality, compliance, and continuous improvement

• Bachelor’s degree in Engineering, Science, or a related field • At least 5 years of quality assurance experience in a medical device company • Experience with Class III cardiovascular medical devices – a must • Experience leading a team of at least 3 employees – a must • In-depth knowledge of FDA 21 CFR Part 820, ISO 13485/14971, and EU MDR • Experience conducting investigations, identifying root causes, leading corrective actions, and applying risk management and statistical tools • Strong written and verbal communication skills, with excellent analytical and problem-solving abilities • Auditor certification and experience with ERP/eQMS systems are an advantage • Excellent English (spoken and written) Location: Sharon District