Quality Systems Specialist

About the Role As a Quality Systems Specialist at the Rice Creek Pharma Operations Manufacturing site in Fridley, MN, you will play a vital role in maintaining and enhancing the Quality Management System (QMS) to ensure compliance with regulatory requirements and internal standards. The role requires a minimum of five days a week onsite. Responsibilities 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 analysis oversight on a continuing basis to enforce requirements and meet regulations. Lead audit and inspection preparation, resolution of audit and inspection findings, and liaise with auditing groups and inspectors through all stages of the audits. Prepare reports and/or necessary documentation (e.g., Corrective and Preventive Actions) and provide them 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 enable best‑practice sharing, thereby fostering the achievement of the company’s mission globally. Qualifications Bachelor’s degree with 2+ years of work experience in Quality or a regulated industry. OR Advanced degree with 0+ years of work experience in Quality or a regulated industry. Hands‑on experience with QMS platforms such as TrackWise. Experience organizing audit backrooms, preparing documentation, and facilitating communication between auditors and teams. Experience assisting CAPA owners with documentation, ensuring process compliance, and monitoring timelines. Experience creating and delivering accurate QMS reports to support quality initiatives and improvements. For bachelor’s degrees earned outside of the United States, a degree that satisfies the requirements of 8C.F.R. §214.2(h)(4)(iii)(A) is required. Benefits & Compensation Salary range: $75,200.00 – $112,800.00 (USD) for U.S. locations. The position is eligible for the Medtronic Incentive Plan (MIP). Benefits include health, dental, vision, Health Savings Account, Flexible Spending Account, life insurance, long‑term disability, dependent daycare, tuition assistance, 401(k) with employer match, short‑term disability, paid time off, paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, and other standard benefits. Equal Employment Opportunity Medtronic is an equal opportunity employer. We do not discriminate on the basis of age, color, national origin, citizenship status, disability, race, religion, creed, gender, sex, sexual orientation, gender identity, marital status, public assistance status, veteran status, or any other characteristic protected by law. We provide reasonable accommodations for qualified individuals with disabilities. #J-18808-Ljbffr MED Medtronic Inc