Director, Quality Assurance

The Director, Quality Assurance will establish, lead, and continuously improve the Quality Management System for CRC EP, Inc., a Biotronik business unit developing pulsed-field cardiac ablation technologies. This role provides strategic Quality Engineering leadership to ensure regulatory compliance, audit readiness, and successful product approvals for Class III cardiac devices. The position requires deep expertise in ISO 13485, EU MDR, FDA regulations, and risk management while partnering with cross-functional teams and external regulatory bodies.