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 Provides regional quality oversight to ensure facilities programs, systems, and processes comply with internal policies and regulatory requirements Serves as a quality subject matter expert supporting audit readiness, CAPA management, training compliance, quality metrics, and standardized best practices across manufacturing and distribution center facilities. 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. Maintain audit tracker data and analyze dashboards to identify trends, risks, and improvement opportunities Partner with regional Facilities leaders on audit performance and readiness Support sites with audit and inspection preparation including onsite support for complex audits Train Facilities Managers on audit preparation, conduct, and regulatory expectations Act as subject matter expert for audit findings and CAPA management including TrackWise support Lead resolution and reporting of audit findings, CAPA status, and key quality metrics Review and standardize facilities-related quality documents and support document owners Serve as subject matter expert for facilities quality systems and related tools Manage training compliance dashboards and support training matrix administration Identify training compliance gaps and drive closure plans Serve as liaison between Facilities, Engineering, and site quality systems for equipment validation activities Promote standardized quality practices and continuous improvement across sites Must Haves Bachelor’s degree and 7 years of experience in Quality Systems OR advanced degree and 5 years of experience 3 years of experience in quality assurance, regulatory compliance, or quality systems Experience supporting audits, inspections, and CAPA management Working knowledge of quality systems, documentation, and training compliance Strong analytical, communication, and cross-functional collaboration skills Nice to Have Experience supporting audits, inspections, and CAPA management Working knowledge of quality systems, documentation, and training compliance Strong analytical, communication, and cross-functional collaboration skills Experience in regulated environments such as medical devices or life sciences Experience with electronic quality systems such as TrackWise Experience supporting multi-site or regional operations Familiarity with facilities equipment validation and quality metrics 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 ... (truncated, view full listing at source)