Quality Engineering Program Manager - SH&A

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 The Structural Heart and Aortic integrated operating unit offers minimally-invasive approaches to restore proper structure and function of the heart and the aorta. We focus on the transcatheter replacement or repair of the four heart valves—aortic, pulmonic, mitral, tricuspid—and the placement of stent grafts to treat aneurysms and dissections of the body’s largest artery, the aorta. _Come for a job, stay for a career!_A Day in The Life Of:

• Leading product escalations across cross functional groups
• Responsible for monitoring product performance, complaint investigations, and evaluating quality issues impacting released product
• Responsible for Design Assurance activities supporting changes to commercial products
• Mentor team members through technical problem solving including CAPA investigations and triaging issues
• Provide technical knowledge and input into risk assessments when quality issues are being evaluated
• Provide front room support during inspections from regulatory agencies (e.g. FDA, FDB, Notified Body)
• Demonstrate the ability to communicate, influence, and negotiate with internal cross-functional employees, internal leaders at all levels and external customers in the pursuit of product quality improvements and post-market risk management
• Create strategic plans for driving efficiencies, improving competencies, and developing people to continuously improve function
• Provide oversight and expertise in risk management activities
• Ability to effectively communicate and provide updates on high visibility patient impacting issues to senior leadership

Key Skills & Experience

• Bachelor's degree and a minimum of 5 years of relevant experience, or advanced degree with a minimum of 3 years of relevant experience
• Working knowledge of FDA regulations and ISO standards applicable to implantable medical devices
• 5 years of experience of working in the regulated medical device industry
• Root cause analysis and leading technical investigations with cross functional groups
• Lead projects to solve technical problems or process improvement programs and ability to manage stakeholders and work cross functionally
• Work on health risk assessments/ product holds and recalls
• Experience of working in post market quality/complaint handling teams

Medtronic Offer a Competitive Salary And Flexible Benefits Package#IJA #INDJPhysical Job Requirements The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.  Benefits & CompensationMedtronic offers a competitive Salary and flexible Benefits Package A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP). About Medtronic We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people. We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. Learn more about our business, mission, and our commitment to diversity here