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

You will be responsible for supporting the scoping of Field Corrective Actions (FCAs) globally. Job duties specifically include ensuring robust FCA communication (1st and 2nd Attempts for Digital and/or Physical mailings, Kaiser Notification, Distributor Notification, and VA Notifications). This position involves coordination with a diverse group of people across Medtronic. The individual for this role will need to work independently and as a team player with the ability to use sound judgement and work through ambiguous situations utilizing peers and leadership for assistance as appropriate.

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

• Manage and execute 1st and 2nd attempt FCA communications for Neuroscience, Medical Surgical and Cardiovascular portfolios, with focus on physical and digital mailings in compliance with regulatory requirements.

• Ensure FCA documents and records are maintained with accuracy and in compliance with good documentation practices and record retention requirements.

• Communicate primarily and frequently with internal contacts. Contact others to share information, status, needs and issues in order to inform, gain input, and support decision-making.

• Track, document, and report mailing outcomes to support audit readiness and ensure closure of communication within defined timelines

• Support continuous improvement projects to increase effectiveness, efficiency, and compliance.

Required Knowledge and Experience: 

• Requires a Bachelor's Degree with 2-3 years of work experience in Quality or regulated industry

• Quality management or document control experience

• Excellent written and verbal communication abilities.

• Experience with Good Documentation Practices

• Excellent knowledge of Excel

• Detail oriented and an agile learner

• Experience working with large sets of data

• Experience with FDA regulatory medical device requirements, 21CFR Part 806, Part 7; ISO 13485, Medical Device Directive

• Capable of effectively managing multiple demands from a variety of sources

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.
 

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