We anticipate the application window for this opening will close on - 29 Aug 2025

 

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life

Medtronic is a world leader in providing health care products that restore health and extend life.  The Medtronic Diabetes R&D team contributes directly to this mission; we deliver software and firmware for Medtronic’s pump and continuous glucose monitoring devices. 

Our business is growing significantly as the market demands reliable medical devices which look and feel more like consumer devices.  We are looking for an Associate Quality Systems Specialist who can help us continue to make devices more robust and reliable for our patients.

This position is an exciting opportunity to work with Medtronic's Diabetes business. Medtronic has announced its intention to separate the Diabetes division to promote future growth and innovation within the business and reallocate investments and resources across Medtronic, subject to applicable information and consultation requirements. This separation provides our team with a bold opportunity to unleash our potential, enabling us to operate with greater speed and agility. As a separate entity, we anticipate leveraging increased investments to drive meaningful innovation and enhance our impact on patient care.

Engineers create our market-leading portfolio of innovations. Join us to make a lasting impact. Help bring the next generation of life-changing medical technology to patients worldwide. This is a unique opportunity to apply your best technical innovation, problem solving and leadership skills to improving how people live their lives every day. 

Minimum Requirements:

Requires a Baccalaureate degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.

NICE TO HAVE:

• Intermediate or better level of experience with Microsoft suite, including but not limited to Word, Excel, SharePoint, Teams, PowerPoint and Adobe
• Experience with Oracle Agile, Trackwise and/or PowerBI systems
• Experience in FDA, Certifying Body and/or Notified Body audits/inspections
• Experience or training in project management
• Experience with medical device industry Regulations, Standards and Quality Management Systems
   

Other Responsibilities:

• Supports 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.
• Conduct quality reviews of Change Orders for Quality Management System documents and records.
• Provides expertise and guidance to stakeholders in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.
• Supports audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits.
• Prepares reports and/or necessary documentation, data analysis, etc. and provides to applicable stakeholders.
• Co-ordinates implementation of enterprise changes within local quality management system.
• Co-ordinates legal requests in support of government investigations or litigations.
• Ensures the quality assurance programs and policies are maintained and modified regularly.
• Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally.
• Leads smaller quality projects and project teams, while facilitating larger quality projects in a variety of roles
   

SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages tasks or project actions assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals
 

DIFFERENTIATING FACTORS

Autonomy: Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments
 

Innovation and Complexity: 

• Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex .
• Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area

Communication and Influence: