Design Quality Manager

Act as an effective team member in supporting quality disciplines, decisions, and practices Provides guidance and leadership to team of direct reports on workload management, priorities, and project execution. Continuously develops direct reports through individual development planning processes. Owns and drives deliverables related to Design Controls, Risk Management, Product Performance, Quality, and Compliance; key partner in all department goals and objectives. Owns and drives product sustainment activities. Maintains and enhances cross-functional team relationships. Provides direction, coaching, and mentoring to engineering and/or technical team personnel. Proactively investigates, identifies, and implements best-in-class quality practices. Determines appropriate staff levels and schedules. Works with key partners to understand priorities and plans resource allocation accordingly. Assures activities and deliverables in area of responsibility meet regulatory and corporate requirements. Foster a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives. Directly interfaces with internal and external audit activities. Partners with internal and external stakeholders and vendors to ensure quality objectives are met and to provide solutions to quality issues. Minimum of a Bachelor's degree Minimum of 5 years of related work experience or an equivalent combination of education and work experience Minimum of 1 years of direct or indirect supervisory experience with a passion for leadership and team development Strong communication skills (verbal & written) Medical Device or regulated industry experience Experience with medical standards compliance, including ISO 13485, ISO 14971 and FDA Quality System Regulations with a focus on design controls and design optimization Ability to travel up to 10% (Domestic and International) Advanced degree in technical field or business Experience leading technical teams Experience in reliability testing