Senior Design Quality Assurance Manager - Endoscopy SUD

Owns and drives deliverables related to Design Controls, Risk Management, Product Performance, Quality, and Compliance. Oversees the Design Controls and Risk Management aspects of Design History File, mitigate risks and ensure compliance with applicable regulatory standards during New Product Development. Translate strategy into action by converting broader organizational goals into specific objectives and tactical plans for the Quality Engineering team. Key focuses include New Product Development projects and goals, complaint reduction, value improvement and product performance challenges. Owns and drives commercial product monitoring and all related product sustainment activities including complaint signal management, CAPA and management of regulator responses. Communicate effectively. Interacts with and influences stakeholders at all levels of the organization, presenting complex challenges in clear and actionable manner. Act as a champion for quality disciplines, decisions, and practices. Lead in guiding team direction and execution of product and divisional programs. Promote accountability and a proactive mindset toward excellence. Provides guidance and leadership to team of direct reports on workload management, priorities, and project execution. Provides mentorship in quality technology, quality principles and overall regulation, risk management and design control concepts. Continuously develops direct reports through individual development planning processes. 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 including direct audit support locally and at several international manufacturing sites. 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 in engineering (Biomedical, Mechanical, Electrical, etc.) or equivalent fields of study Minimum of 8 years of related work experience in Design Quality or an equivalent combination of education and work experience Minimum of 3 years of direct or indirect supervisory experience with a passion for leadership and team development 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, risk management and design optimization Ability to travel up to 10% (Domestic and International) Advanced degree in technical field or business Experience leading technical teams Strong strategic and critical thinking capabilities with the ability to balance long-term vision with executional excellence Excellent collaboration, communication, and interpersonal skills with the ability to work across cultures and geographies Ability to drive change in a matrixed, global organization Experience with problem solving including Six Sigma Certification(s) Strong communication skills (verbal & written) in a technical environment