Quality Systems Specialist

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.

About the role

As a Quality Systems Specialist, you will play a vital role in maintaining and enhancing the Quality Management System (QMS) to ensure compliance with regulatory requirements and internal standards. Your expertise will support audit activities, CAPA documentation, and reporting processes, contributing to the overall success of the organization's quality initiatives at the Rice Creek Pharma Operations Manufacturing site in Fridley, MN.

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 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

• 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 analyses 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 Preventative Actions) and provide 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.

Requirements

• Bachelor's degree with 2+ years of work experience in Quality or regulated industry OR Advanced degree with 0+ years of work experience in Quality or regulated industry.
• 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.

Nice to Have

• Organize audit backrooms, prepare documentation, and facilitate communication between auditors and teams.
• Assist CAPA owners with documentation, ensure process compliance, and monitor timelines.
• Create and deliver accurate QMS reports to support quality initiatives and improvements.
• Hands-on experience with QMS platforms such as TrackWise.

Physical Job Requirements

The physical demands described 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.

U.S. Work Authorization & Sponsorship

At Medtronic, 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

The following benefits and additional compensation are available to regular employees who work 20+ hours per week:

• Health, Dental, and Vision insurance
• Health Savings Account
• Healthcare Flexible Spending Account
• Life insurance
• Long-term disability leave
• Dependent daycare spending account
• Tuition assistance/reimbursement
• Simple Steps (global well-being program)
• Incentive plans (Medtronic Incentive Plan - MIP)
• 401(k) plan plus employer contribution and match
• Short-term disability
• Paid time off and paid holidays
• Employee Stock Purchase Plan
• Employee Assistance Program
• Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
• Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)

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. Note: Some benefits may not apply to workers in Puerto Rico.

Pay

Salary ranges for U.S. (excluding PR) locations (USD): $75,200.00 - $112,800.00. 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 Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location.

Schedule

This role requires working a minimum of 5 days a week onsite.