Senior Quality System Manager - NM - Rice Creek/Fridley, MN (Onsite)
Medtronic · Fridley, Minnesota, United States of America
Job description
We anticipate the application window for this opening will close on - 18 Jul 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 LifeAs one of three comprehensive portfolios at Medtronic, Neuroscience is dedicated to improving the lives of people living with neurological disorders, spine conditions, and chronic pain. Guided by our Mission—to alleviate pain, restore health, and extend life—we develop technologies and therapies that help people regain function, reduce pain, and return to the activities that matter most. Our Neuromodulation Operating Unit provides advanced therapies for chronic pain, movement disorders, and other neurological conditions. Through spinal cord stimulation, deep brain stimulation, and targeted drug delivery systems, we deliver personalized treatments that restore function, reduce symptoms, and improve quality of life worldwide. Check us out on LinkedIn: Medtronic Brain Modulation and Pain Interventions A Day in the Life The Senior Quality Systems Manager provides strategic leadership for the Quality Management System (QMS), ensuring its effectiveness, regulatory compliance, and continuous improvement. This role is accountable for overseeing the Corrective and Preventive Action (CAPA) program and key quality system processes, including quality planning, management review, quality metrics, training, change control, and enterprise quality initiatives. By driving governance, cross-functional collaboration, and operational excellence, the Senior Quality Systems Manager ensures timely issue resolution, effective quality system performance, and alignment with business and regulatory requirements. Responsibilities may include the following and other duties may be assigned. Provide strategic and operational leadership for the Quality Management System (QMS) and continuous improvement initiatives. Lead the governance and oversight of the CAPA program, ensuring timely execution, effectiveness, and regulatory compliance. Oversee core quality system processes, including change control, training, management review, quality planning, and quality metrics. Monitor quality system performance, identify trends, and drive improvements through data-driven decision making. Partner cross-functionally to ensure quality system processes support business objectives while meeting applicable regulatory and quality requirements. Establish and maintain effective governance for quality system changes and enterprise quality initiatives. Support internal and external audits, regulatory inspections, and remediation activities as needed. Foster a culture of quality, accountability, and continuous improvement across the organization. Location: Rice Creek East/Fridley, MN (Onsite) Onsite: At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. We’re working onsite 4 days a week to drive performance, foster an environment of belonging, and collaborate to inspire as we engineer the extraordinary. This role will require 10% of travel to enhance collaboration and ensure successful completion of projects. Must Have (Minimum Requirements) To be considered for this role, please ensure the minimum requirements are evident on your resume. Bachelor’s degree required with a minimum of 7 years in Quality Systems within the medical device industry with 5+ years of people management experience. OR advance degree with a minimum of 5 years in Quality Systems within the medical device industry with 5+ years of people management experience. Nice to Have (Preferred Qualifications) Strong understanding of global regulatory requirements for medical devices, including FDA Quality Management System Regulation (QMSR), ISO 13485, and European Medical Device Regulation. Excellent written and verbal communication skills, with the ability to influence stakeholders and communicate effectively across all levels of the organization. Demonstrated experience managing or leading CAPA processes in a regulated environment, including issue assessment, investigation, root cause analysis, action planning, implementation, and effectiveness verification. Demonstrated leadership capability, including coaching others, driving cross-functional collaboration, and fostering a culture of quality and continuous improvement. Strong understanding of quality systems, including change control, nonconformance management, risk management and management review. Strong analytical and problem-solving skills, with experience using structured methodologies to support fact-based decision-making. 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):$149,600.00 - $224,400.00 This position is e
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