Senior Quality Assurance Engineer (Change Control & Complaints)

Lead and coordinate the Change Control process, ensuring appropriate assessments, approvals, implementation, training, compliance, and effectiveness monitoring. Review and approve product complaints, support investigations, monitor trends and quality signals, and contribute to risk management activities based on post-market surveillance data. Support internal, external, and regulatory audits and inspections, drive quality improvement initiatives, manage deviations, non-conformances and CAPAs within scope, and ensure compliance with applicable medical device and pharmaceutical regulations.