Sr. Quality Program Manager (Medical Device)

We anticipate the application window for this opening will close on - 27 Apr 2026 At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. Join Medtronic as a Senior Quality Program Manager – Quality Core Team Member (QCTM) and be at the forefront of transforming lives through advanced medical technology. In this highly visible role, you will serve as the Quality Core Team Member for complex cardiac electrophysiology programs, working in close partnership with R&D, Systems Engineering, Manufacturing, Regulatory, Clinical, and Operations to drive the successful development, transfer, and sustainment of Affera products. By blending technical quality expertise , program leadership , and a deep commitment to patient safety, regulatory compliance, and design excellence , you will play a critical role in ensuring robust design execution and high‑quality product delivery as Affera technology continues to scale globally. Primary Responsibilities Acts as the Quality Core Team Member (QCTM) and program‑level Quality lead for assigned product development programs, with accountability for quality strategy, execution, and outcomes across the full product lifecycle. Plans, directs, and oversees all Quality aspects of design and development , ensuring compliance with Medtronic policies, global regulatory requirements, and applicable quality system regulations. Leads and integrates Quality program planning , including design control strategy, design verification planning, risk management planning, design transfer readiness, and post‑market quality considerations. Provides Quality leadership for design verification and validation activities , including review and approval of test strategies, protocols, methods, execution readiness, and test results. Ensures robust test method development, qualification, and validation , partnering with engineering, manufacturing, and suppliers to establish reliable, reproducible, and compliant methods. Owns and drives product and process risk management activities , including hazard analysis, FMEAs, and risk/benefit assessments, ensuring alignment with system architecture, clinical intent, and real‑world use. Leads Quality oversight for design transfer , collaborating with manufacturing, supplier quality, operations, and regulatory partners to ensure product and process readiness for commercialization. Guides cross‑functional teams through phase gate reviews , design reviews, and key quality decision points, providing clear recommendations and risk‑based decision support. Monitors and ensures the integrity of design history file (DHF) documentation , traceability, and configuration management throughout the development lifecycle. Coordinates Quality activities with external suppliers, test labs, and consultants , ensuring timely delivery, compliance, and risk mitigation. Identifies gaps, risks, and improvement opportunities within Quality processes and program execution; drives corrective actions and continuous improvement initiatives. Is a mentor, leader or direct manager to earlier career QCTMs Other duties may be assigned Required Qualifications Bachelor's degree and a minimum of 7 years of relevant experience OR an advanced degree with a minimum of 5 years of relevant experience Preferred Qualifications Experience working with Class III medical devices . Broad knowledge of Quality sy ... (truncated, view full listing at source)