How you can make a difference: Maintain and continuously improve the company's Quality Management System in accordance with ISO 13485, FDA QMSR, EU MDR, MDSAP, and other applicable regulations. Ensure alignment of quality system processes with business objectives and regulatory expectations. Monitor regulatory changes and assess impacts on the QMS. Drive harmonization and standardization of quality processes across sites in Switzerland, Romania and USA. Audit and Inspection Management Lead internal audit programs and ensure compliance with audit schedules. Coordinate external audits conducted by Notified Bodies, regulatory authorities, MDSAP Auditing Organizations, and customers. Serve as a key representative during inspections and audits. Ensure timely resolution of audit findings and effectiveness of corrective actions. Compliance and Regulatory Support Partner with R&D, Regulatory Affairs, Manufacturing, Engineering, Service, and Operations to ensure ongoing compliance. Support product registrations and submissions through provision of QMS-related documentation. Ensure inspection readiness across all functions. Support regulatory agency interactions as required.
For more than 40 years, Hamilton Medical has shaped the future of mechanical ventilation. We develop Intelligent Ventilation solutions that support clinicians in critical moments. Our Hamilton ventilators are used in intensive care units, during emergency transport, and in MRI environments. They help medical teams care for adult, pediatric, and neonatal patients worldwide. Here, your work has real impact. Every improvement you make supports better respiratory care for patients around the globe.
