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Principal Clinical Quality Systems Specialist

19000F4L Requisition #

Location:  Minneapolis, MN

Careers that Change Lives

Help lead the effort to create global strategies for worldwide medical device approvals to introduce new products to market.

Come for a job, stay for a career.
A Day in the Life

As a member of Corporate Clinical Quality & Compliance, the Principal Clinical Quality Systems Specialist is responsible for assuring that personnel across Medtronic are educated in, and operating within, U.S. and international regulatory requirements and standards, focused on innovative clinical evidence generation (e.g. use of real world evidence, retrospective database analyses, outcome data collections, health care economics, etc.). This includes the development of Medtronic policies and procedures in the space of innovative evidence generation and facilitating continuous improvements to processes and procedures. 


The Principal Clinical Quality Systems Specialist works without appreciable direction and exercises considerable latitude in determining objectives of assignment(s) and compliance-orientated solutions to a wide range of difficult problems and innovative approaches.  These solutions require regular use of ingenuity, influence management skills, innovative thinking and creativity.  Completed work is reviewed from a relatively long-term perspective, for desired results.


This position applies extensive technical expertise in the space of innovative evidence generation and has full knowledge of other related disciplines. Represents the organization as a technical contact and interacts with senior personnel on significant technical matters often requiring coordination between organizations/ functions.  The Principal Clinical Quality Systems Specialist may provide guidance to lower level personnel.


Responsibilities may include the following and other duties may be assigned.

  • Develops, implements and maintains policies and procedures aligned with relevant global regulations and standards
  • Assists in the development and implements programs designated to increase employee awareness and knowledge of compliance
  • Acts as an advisor on clinical quality assurance issues
  • Identifies and leads clinical quality process improvement initiatives
  • Partners with Clinical Quality Auditors to establish audit criteria for selecting innovative evidence projects in the audit program and defining audit criteria for project audits
  • Provide consultation to CAPA owners to facilitate identifying root cause and development of appropriate action plans
  • May perform role of guest auditor or subject matter expert during internal quality audits to assess accuracy and quality of evidence generation May support the development of assessment tools, training programs, policies and interpretation of requirements.
  • May partner with Clinical Quality Training Specialists to facilitate training for Medtronic personnel.

Must Have: Minimum Requirements

To be considered for this role, the minimum requirements must be evident on your resume. 

  • Bachelor’s degree with a minimum of 7 years of experience supporting clinical research/quality audits/compliance within the healthcare industry or advanced degree with a minimum of 5 years of experience supporting clinical research/quality audits/compliance within the healthcare industry
Nice to Have:    
  • Clinical Research / Quality audit / Quality system experience at Medtronic or within the medical device industry.
  • Knowledge and experience with FDA and international regulations (e.g., 21 CFR 812, 11, 50, 54, 56, 803, 806, 820, ISO 13485, ISO 14155) and/or experience in Quality System regulations.
  • Knowledge and/or experience in non-traditional clinical evidence generation
  • Experience in Good Clinical Practice (GCP) and/or regulatory compliance guidelines for clinical trials
  • Significant knowledge of clinical and outcomes research study design
  • Ability to incorporate and adhere to good clinical practices and regulatory standards
  • Database validation
  • Proficient knowledge of medical terminology.

About Medtronic

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be. 

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future. 

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. (ADA-United States of America)


Travel is required up to 25%.

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Alyse is an Engineering Program Manager for Neuromodulation in Minneapolis, Minnesota.

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The mission to improve access to healthcare globally is something we are all very proud to work hard toward achieving. Great people, fun atmosphere, big city salaries. The CEO is fantastic - he is a very clear communicator of the mission and is truly dedicating his life to achieving it.
Smart and committed coworkers. Mission driven. Good benefits. Good long term career opportunities. Company is large enough that you can always find interesting projects to work on.
Knowing that everyday your work helps to save lives makes it great place to work. Training on lean practices, quality and other. Excellent peers.


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