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Quality Applications Specialist

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Quality
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19000CQ0 Requisition #

Careers That Change Lives


 

Are you a passionate, dedicated and motivated Quality Applications Specialist that thrives on supporting medical device quality systems, design, and post market vigilance?

 

Come for a job, stay for a career.

 

As a Quality Applications Specialist in Operations Excellence has the responsibility to support medical device quality including quality systems, design and post market vigilance utilizing a variety of analytical skills and methodologies. Support will be provided for vigilance, compliance and strategic activities as part of the Quality Program Management organization, including analyzing large data sets pertaining to risk management, complaints, CAPA, etc. This role may work cross functionally with IT, Operations, R&D and Quality.

 

The Restorative Therapies Group develops life-restoring therapies and healthcare solutions that span the care continuum; integrating technologies and applying clinical and economic evidence to increase patient access, improve efficiency of procedures and deliver successful patient outcomes.

 

BRAIN THERAPIES offers an integrated portfolio of devices
and therapies for the treatment of neurological disorders and diseases, as well as surgical technologies designed to improve the precision and workflow of neuro procedures.

 

A Day in the Life

 

Careers that Change Lives

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

  • Conducts a compliant validation process for quality information technology systems which requires formal validation documentation (including standard operating procedures) under appropriate federal regulations.
  • Coordinates activities with clients, programmers/developers and operating personnel, domestic and, as appropriate, global.
  • Identifies current and anticipated requirements for compliant computerized operations and suggests methods for the identification, implementation and maintenance of the procedures, actions and documentation necessary to assure compliance according to the appropriate federal and international regulations which govern the user's applications.
  • Reports on the status of validation activities to fulfill regulatory requirements.
  • Keeps abreast of changing federal and international regulatory requirements, government audit policies, and the availability of current techniques.
  • Performs system administration and configuration of quality information technology systems.

Other responsibilities may include:

·       Compile, enter and interpret data and analyze results using statistical techniques.

·       Execute quantitative analyses that translate data into actionable insights. Provide analytical and data-driven decision-making support for key projects.

·       Develop and automate reports meeting the needs of stakeholders. Work with stakeholders to establish the right metrics for monitoring the business.

·       Work with stakeholders to gather functional requirements and work with IT and engineering to help deliver data driven solutions.

·       Communicate findings on a regular basis to leadership.

·       Assist in defining and driving standards for data management including innovative solutions for data reporting and trending.

·       Validate solutions

 


Must Have: Minimum Requirements

 

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

 

  • Bachelors degree required
  • Minimum of 2 years of experience, or advanced degree with 0 years of experience

Nice to Have: Preferred Qualifications

 

·   Bachelor’s degree in mathematics, computer science, statistics, business or engineering preferred.
  • 5+ years of experience as an analyst in a data and analytics domain
  • 2+ years of experience with medical device analytics
  • Experience in the area of data analysis and
  • Experience with data entry and analysis in Excel
  • Demonstrated ability to turn data into information that helps drive decisions.
  • Effective at influencing and building strong working relationships across all levels and diverse cultures
  • Demonstrated experience in accomplishing objectives.  Able to deliver on multiple projects simultaneously.
  • Master’s degree is preferred.
  • Experience with SpotFire, Cognition Cockpit and/or Tableau

 

Medtronic Benefits

·       Industry-leading Healthcare

·       Competitive Retirement and Stock   Programs

·       Educational Resources and Financial Assistance

·       Family Care Leave

·       Matching Gift and Volunteer Grants

·       Opportunities to Network and Grow

·       Mentoring

·       Flexible Paid Time Off

·       Well-being Resources, Activities and Rewards

·       A “Thank-You” Culture

 

 

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 Day in the Life 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.

 

EEO

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

 

This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here: http://www.uscis.gov/e-verify/employees

 

 


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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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