Senior Quality Systems Specialist

We anticipate the application window for this opening will close on - 2 Mar 2026

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.#
** A Day in the Life
** Act boldly. Compete to win. Move with speed and decisiveness. Foster belonging. Deliver results…the right way. That’s the Medtronic Mindset — our cultural norms. Our brand is rooted in action, not just words. The Medtronic Mindset defines the expectations of our culture. Every person here plays a role in bringing it to life. We recognize your extraordinary potential to ensure future generations live better, healthier lives.

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.

Responsibilities may include the following and other duties may be assigned.
* 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 (ex Corrective and Preventative Actions) and provide to applicable stakeholders, both internal and external.
* Co-ordinate 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 enables best practice sharing, thereby fostering the achievement of company's mission globally.

This role is
** 100% onsite
** at our Rice Creek, MN site and travel between the Twin City campuses as needed.
** Must Have:

Minimum Requirements
*** To be considered for this role, please ensure the minimum requirements are evident in your applicant profile.
** Bachelor's degree with 4+ years of work experience in Quality or regulated industry OR Advanced degree with 2+ years of work experience in Quality or regulated industry
** Nice to Have
*** Organize audit back rooms, 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.
** 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.#
** Benefits & Compensation
**** Medtronic offers a competitive…