Device Quality and Risk Management Engineer

The Device Quality and Risk Management Engineer supports medical device quality and risk management activities for existing and new products throughout the product lifecycle. This role assists with design controls, risk management, quality system compliance, investigations, CAPA, supplier quality, and regulatory inspections under the guidance of senior personnel. The position works collaboratively with cross-functional teams to support risk-based decision making and help ensure device products comply with FDA QMSR, ISO 13485, EU MDR, and internal quality system requirements.