Senior Quality System Manager - NM - Rice Creek/Fridley, MN (Onsite)

About the role

The Senior Quality Systems Manager role is part of the Neuroscience portfolio at Medtronic, a global leader in healthcare technology. This position is responsible for leading the Quality Management System (QMS) and ensuring its effectiveness, regulatory compliance, and continuous improvement.

Responsibilities

• Provide strategic and operational leadership for the Quality Management System (QMS) and continuous improvement initiatives.
• Lead the governance and oversight of the Corrective and Preventive Action (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.

Requirements

• 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

• 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.

Location

Rice Creek East/Fridley, MN (Onsite)

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.

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.

Benefits & Compensation

Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico. Further details are available at the link below: Medtronic Benefits And Compensation Plans