Senior Design Assurance Quality Engineer II

The Senior Design Assurance Quality Engineer acts as a core team member for Global Quality and Regulatory Affairs, driving compliance for new product development and changes. This role involves guiding cross-functional teams on design controls, facilitating verification and validation activities, and conducting risk assessments in accordance with global regulatory requirements and ISO 14971 standards. The position requires independent evaluation of quality techniques and interfacing with plant and supplier teams to ensure product qualification prior to market release.