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21000T78 Requisition #
Careers that Change Lives

In this exciting role as a Sr. Quality Systems Specialist you will have responsibility for compliance to Quality System processes, external and internal Audit, and Medical Device regulations and requirements.  

Structural Heart and Aortic

The Structural Heart and Aortic integrated operating unit offers minimally-invasive approaches to restore proper structure and function of the heart and the aorta. We focus on the transcatheter replacement or repair of the four heart valves—aortic, pulmonic, mitral, tricuspid—and the placement of stent grafts to treat aneurysms and dissections of the body’s largest artery, the aorta.

A Day in the Life

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

  • Provide continuous and rigorous assessment of quality system and audit activities and documentation to assure compliance with Medtronic internal policies in general and specific to quality system processes, FDA regulations, ISO 13485, Medical Device Requirements, and governmental regulations.
  • Participates in Quality System process activity across multiple sites including quality system projects and initiatives.  Leads quality system projects.  Provides guidance, support and mentors quality process owners.  
  • Participates in Audit activity.  Performs Audit Coordinator role for multiple sites.  Provides guidance, support and mentor audit finding owners, Audit best practices, Audit record content, and Audit software tools.
  • Provide Quality System metrics and reporting on critical aspects regarding the health of the quality system.
  • Support the development and implementation of Quality System procedures.
  • Supports internal and external audits and inspections for quality system records and processes.  
  • Participates in audits and inspections in multiple audit support roles in the front and back room.  
  • Performs other related duties as assigned.

Must Have: Minimum Requirements

  • Bachelor's degree with 4+ years of work experience in Quality, Manufacturing, or regulated industry OR Advanced degree with 2 years of work experience in Quality or regulated industry

Nice to Have
  • Experience in a regulated environment
  • Experience working with audit findings, corrections, and corrective actions 
  • Experience in medical device, pharmaceutical and/or a comparable regulated environment
  • Influence management skills; ability to work constructively across all functions of the organization as well as external customers
  • Project management skills
  • Quality System documentation systems (e.g. Agile) and Audit documentation systems experience (e.g. Trackwise)
  • Experience reviewing technical documentation
  • Strong written and verbal communication skills
  • Ability to educate people in Quality Systems and the Audit program
  • Experience with quality tools and process improvement techniques
  • Knowledge of effective root cause investigation, corrective and preventive action planning and execution and verification of effectiveness techniques
  • Strong analytical and decision-making skills
  • Understanding of FDA regulations (21 CFR 820, 210/211 as applicable and Part 11), ISO 13485, and Medtronic quality requirements in general and specific to CAPA.

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 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)

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