Principal Quality Systems Specialist

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 Our Coronary & Renal Denervation group is looking for their next Principal Quality Systems Specialist. In CRDN, we love what we do. That's because we're passionate about the patients we serve around the globe and the "second life" and improved health we can give to those with Coronary Artery Disease, High Blood Pressure, and other conditions. We're also driven by the promise of Renal Denervation and its potential to change the way patients around the world manage their uncontrolled hypertension. 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 are working onsite a minimum of 4 days per week as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. This role will require less than 10% of travel to enhance collaboration and ensure successful completion of projects. Responsibilities may include the following and other duties may be assigned: Provide oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines Provide expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance Work directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations Lead audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits Prepare reports and/or necessary documentation (ex Corrective and Preventative Actions) and provide to applicable stakeholders, both internal and external Coordinate legal requests in support of government investigations or litigations Ensure the quality assurance programs and policies are maintained and modified regularly Facilitate uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally Required Knowledge and Experience: Baccalaureate degree with a minimum 7 years of relevant experience OR Advanced degree with a minimum of 5 years of relevant experience For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required. Physical 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. The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. U.S. Work Authorization & Sponsorship At Medtronic, we are committed to fostering an environment where employees can thrive and make a meaningful impact. In alignment with our enterprise-wide workforce p ... (truncated, view full listing at source)