Quality Systems Specialist

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

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.

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

• 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
  
  
  

Required Knowledge and Experience:

• Bachelor’s Degree in Pharmaceutical Sciences, Industrial Engineering, Biomedical Engineering, or field related experience
• Experience with medical device industry Regulations, Standards and Quality Management Systems
• 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
  
  
  

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. 

Benefits & Compensation

Medtronic offers a competitive Salary and flexible Benefits Package

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.

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

About Medtronic

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.

Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people.

We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.

Learn more about our business, mission, and our commitment to diversity here