Quality Systems Specialist

Description du poste:

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 committed to advancing global healthcare by addressing the needs of more people, in more ways, and in more places around the world. United as one company, we accelerate meaningful innovation - and we can only succeed with the right people on our team.

We are seeking a Regional Field Corrective Action (FCA) Coordinator to join Medtronic's Center-Led Post-Market Vigilance team. In this role, you will be responsible for the effective planning, coordination, and oversight of Field Corrective Actions within your assigned region, in alignment with Medtronic's established FCA procedures and work instructions. As the primary liaison between regional sales, marketing, and field teams; quality assurance; the Enterprise Core Quality Services (CQS) function; and global Operating Unit (OU) Quality leadership, you will ensure the timely and compliant execution of all FCA activities. This position plays a critical role in protecting patient safety and maintaining regulatory compliance by ensuring that all regional FCAs are carried out efficiently, accurately, and transparently.

Responsibilities may include the following and other duties may be assigned:
* Coordinating FCA Deployment: managing the regional rollout of FCAs, including communication with local/regional Quality and Regulatory Affairs (QARA) departments, field representatives, sales and marketing management.
* Documentation & Compliance: ensuring all FCA-related documents, including the Global FCA Plan, Field Safety Notice, and Customer Acknowledgement forms, are documented according to Medtronic's work instructions, and that regulatory and quality requirements are met.
* Training & Support: providing guidance and training to field staff on FCA procedures and best practices.
* Audit Support & Notification: supporting OU and local Audit programs, including providing evidence of FCA Planning activities and appropriate competent authority or notified body notification when needed.
* Continuous Improvement: identifying opportunities to enhance FCA processes and collaborating with cross-functional teams to implement improvements.

Required Knowledge and Experience:
* Bachelor's degree in Life Sciences or a related field.
* Fluency in English, both written and spoken.
* Minimum of 2 years of experience in quality systems or regulatory affairs, plus at least 2 years of project management experience in a regulated environment.
* Experience supporting quality system audits (preferred).
* Strong project management capabilities.
* Excellent written and verbal communication skills.
* Exceptional critical thinking and analytical skills.
* Ability and willingness to work onsite at least three days per week.

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