Quality is everyone's responsibility!

Medtronic is a world leader in providing health care products that restore health and extend life. The Medtronic Diabetes Quality team contributes directly to this mission.

We are looking for a Quality Systems Specialist to join the Quality Systems team to ensure a mature and compliant quality management system. You will be a part of a team that supports day-to-day maintenance of the quality management system (QMS) and quality programs to ensure compliance with policies, regulations and standards. In addition, you will drive or support improvement activities to enhance our QMS strategy.

This is a unique opportunity to apply your effort and skills to improving how people live their lives every day.

A Day in the Life

• Use excellent verbal and written communication skills to communicate and collaborate.
• Build and maintain positive relationships across the organization with strong relationship skills and act as a quality partner to other groups.
• Coordinate with team members, manager and other stakeholders to support both day-to-day activities and long term goals.
• Contribute to QMS quality by identifying, collaborating, creating and/or completing process improvements changes.
• Review and drive QMS changes to support product and process releases and updates, sourced from local and enterprise level.
• Support monthly and quarterly quality metric reviews (as well as others) by facilitation, communicate, review and recording.
• Use critical thinking and data analysis to identify outliers or concerns and act to resolve.

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

• Provides 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.
• Provides expertise and guidance to co-workers in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.
• Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations.
• Supports audit and inspection preparation, resolution of audit and inspection findings through all stages of the audits.
• Prepares reports and/or necessary documentation and provides to applicable stakeholders, both internal and external.
• Leads or supports compliance related activities like audit readiness, Corrective and Preventative Actions (CAPA), process improvement.
• Ensures the quality assurance programs and policies are maintained and modified regularly.
• May act as back-up for software validation or other quality activities as needed.
• Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally.

• Bachelor’s degree required with minimum of 2 years of relevant experience
• or, advanced degree with 0 years of experience.

Nice to Have

• Experience in:
  • Medical device industry with relevant regulatory and standards knowledge
  • Audit Backroom and/or Front Room roles
  • Corrective and Preventative Actions (CAPA)
  • Problem solving or process improvement methodology (e.g. Six Sigma, Lean, 5 Why, Kaizen)
  • Software Systems: Agile, Trackwise, Microsoft Teams, Excel, Project, etc.

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)

A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Learn more about our benefits here .

In addition to Base Salary, this position is eligible for a short-term incentive plan, which provides the opportunity to earn significant incentive compensation for achieving or exceeding your goals. This position is eligible for an annual long-term incentive plan. Learn more about MIP Eligible: This position is eligible for a short-term incentive plan. Learn more about Medtronic Incentive Plan (MIP) here .

The provided base salary range is used nationally in the United States (except in Puerto Rico and certain CA locations). The rate offered is compliant with federal/local regulations and may vary by experience, certification/education, market conditions, location, etc.