QA Manager

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