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Sr Quality Systems Specialist (CAPA)

19000N5F Requisition #
Thanks for your interest in the Sr Quality Systems Specialist (CAPA) position. Unfortunately this position has been closed but you can search our 828 open jobs by clicking here.

Must Have: Minimum Requirements


To be considered for this role, please ensure the minimum requirements are evident on your resume.

  • Bachelor’s degree required

  • Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience

Nice to Have

  • Experience in medical device, pharmaceutical and/or a comparable regulated environment.

  • Experience reviewing technical documentation.

  • Experience working with non-conformances, corrective and preventive action reports.

  • Understanding of the following: 

    • FDA 21CFR parts 820 and 11

    • ISO 13485

    • ISO 14971

    • Medical Device Directive

    • Canadian Medical Device Regulation

    • Japanese PAL regulation

    • Other applicable Harmonization Standards that apply to medical devices and instrumentation.

  • Experience in external inspections by regulatory bodies.

  • Experience in a matrix organization.

  • Influence management skills; ability to work constructively across all functions of the organization as well as external customers.

  • Strong written and verbal communication skills.

  • Strong analytical and decision-making skills.

  • Project and time management skills.

  • Experience with quality tools and process improvement techniques.

  • Knowledge of effective root cause investigation, corrective and preventive action planning, execution, and verification of effectiveness techniques.

  • Technical project management or quality engineering experience

  • Ability to educate people in Quality Systems and exercise good judgement


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)


Travel may be required (less than 10%)



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Change Begins With You

We look for bold ideas and fresh insights - that's what drives innovation. Come drive the future of healthcare with us.


The opportunity to invent. The benefit of joining a leader. The power to improve lives. You’ll find all that and more here.

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Bring life-changing solutions to those who need them. Be rewarded for rewarding work.

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Join us in our challenge to make global healthcare more affordable and accessible. Your insight and oversight will help us create solutions that change the world.

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Read About The
Medtronic Mission.

Our mission “to alleviate pain, restore health, and extend life” is more than a statement. It’s a belief that our employees live every day.

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

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Our employees come from varied backgrounds with a common goal—changing lives.

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We value what
makes you

Join us, and bring the power of your unique point of view to our culture of collaboration and innovation.

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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.


Be part of one of the world’s leading medical technologies and solutions companies.