Quality Systems Manager - Plymouth, MN

Job description

We anticipate the application window for this opening will close on - 28 Sep 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the LifeThe Quality Systems Manager provides leadership for the Quality Management System (QMS) at Medtronic's Nathan Lane manufacturing site in Plymouth, Minnesota. Supporting the production of life-changing medical technologies within the Peripheral Vascular Health portfolio, this site is a high-volume, highly regulated manufacturing operation focused on delivering safe, effective, and reliable products to patients around the world. In this role, you will partner closely with Operations, Quality, Manufacturing Engineering, Supply Chain, and Regulatory partners to ensure quality systems remain compliant, effective, and aligned with business objectives. As a key member of the site quality organization, the Quality Systems Manager will lead continuous improvement initiatives across core quality system processes, including compliance, audits, CAPA, document control, training, and management review activities. This leader will drive a culture of quality and operational excellence, ensuring regulatory requirements are met while enabling the business to scale, innovate, and continuously improve. The role requires strong cross-functional collaboration, sound decision-making, and the ability to influence stakeholders at all levels while advancing Medtronic's Mission to alleviate pain, restore health, and extend 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 5 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. Responsibilities may include the following and other duties may be assigned. Provides 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. Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance. Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations. Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits. Prepares reports and/or necessary documentation (ex Corrective and Preventative Actions) and provides to applicable stakeholders, both internal and external. Co-ordinates legal requests in support of government investigations or litigations. Ensures the quality assurance programs and policies are maintained and modified regularly. Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally. Required Qualifications Bachelor's degree with a minimum of 5 years relevant experience, or advanced degree with a minimum of 3 years prior relevant experience Preferred Qualifications Bachelor's degree in Engineering, Quality, Life Sciences, or a related technical field. Experience supporting Quality Management System (QMS) processes, including CAPA, nonconformance, change control, document control, training, or management review. Experience supporting FDA inspections, ISO 13485 audits, MDSAP audits, customer audits, or internal quality audits. Experience interpreting and applying FDA Quality System Regulation, ISO 13485, MDSAP, or other regulated quality system requirements. Experience supporting quality systems within the medical device, pharmaceutical, biotechnology, or other regulated industries. Experience partnering with Manufacturing, Operations, Engineering, Regulatory Affairs, or Supply Chain functions. Experience developing, monitoring, or reporting quality system metrics. Experience supporting quality systems in a manufacturing environment. Experience leading quality, compliance, audit, or continuous improvement projects. ASQ certification such as Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), Certified Manager of Quality/Organizational Excellence (CMQ/OE), or equivalent. 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 planning approach, U.S. work authorization sponsorship (H-1B, TN, J, etc.) is offered exclusively for Principal-level roles and above, where specialized expertise aligns with long-term business needs. Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment. ‌ Recruitment Fraud Alert We are aware of phishing scams targeting job seekers. Please keep the following in mind: Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @medtronic.com email addresses. Medtronic will never ask for payment or sensitive personal information (such as bank account or Social Security details) during early stages of the hiring process. Any such requests are not legitimate. If you receive a suspicious message claiming to be from Medtronic, do not respond, click links, or open attachments. If you have any questions, concerns regarding the authenticity of a communication alleged to have been made by or on behalf of Medtronic, please contact us immediately at AskHR@medtronic.com. ‌ Benefits & Compensation Medtronic 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. Salary ranges for U.S (excl. PR) locations (USD):$120,000.00 - $180,000.00 This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP). The base salary range is applicable across the United States, excluding