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

We are seeking a driven and talented individual to join our Quality team. This individual will bring a passion for continuous improvement, a strong communication skill set, and an ability to have an attention to detail in combing through data and finding trends, as they relate to the software applications we support.

This position requires the ability to support the Medtronic IT systems validations, maintenances, strategies and accurate review of specific documentation as required by the IT quality processes. The position requires the understanding of auditing and investigation techniques to ascertain potential areas of risk, qualify their severity and address gaps in a methodical way to reduce overall organization exposure.

A day in the life:

• Provides oversight systems validations, maintenances, strategies and accurate review of specific documentation as required by the IT quality processes that ensure compliance with established standards and regulations
• Contributes to simplified validation approaches and coaching on how to leverage these approaches with their projects including resources like Business Analysts, Developers, Testers, and Project Managers
• Collaborates with global IT quality peers and project teams on project scope, schedule and compliance guidance
• Supports the external audit IT team on timely retrieval of quality documentation related to the systems, reports, and spreadsheet validation efforts they manage

Required knowledge:

• Bachelor’s degree
• Experience to work in a global, virtual organization
• Solid understanding of the quality regulations and auditing techniques required for the medical device industry
• Ability to create and deliver presentations up to the Executive Committee level
• Strong influencing and negotiation skills
• High energy and motivation with an ability to quickly adapt to change
• Frequent interaction with internal or external contacts at various organizational levels concerning ongoing operations or changes relating to quality and compliance processes or programs

NICE TO HAVE (Preferred Qualifications)

• Previous Medtronic experience
• Product, non-product or healthcare software validation delivery experience
• Lean six sigma green / blackbelt or DMAIC skills
• CAPA root cause analysis methods skills

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