Über diese Associate Quality Systems Specialist Stelle bei Medtronic
Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.
A Day in the Life
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.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 EMEA and Canada 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.
This role is based in Heerlen, Netherlands.
Primary responsibilities:
- Coordinating FCA Deployment to ensure alignment with regulatory expectations: 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 qualifications:
- Bachelor/Master degree in Life Sciences or a related field. 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.
- Fluency in English, both written and spoken with excellent written and verbal communication skills
- Basic understanding of global regulatory requirements for medical devices (e.g., FDA, EU MDR, ISO 13485, Health Canada SOR/98-282).
- Strong project management capabilities.
- Exceptional critical thinking and analytical 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.
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Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @medtronic.com email addresses.
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If you have any questions, concerns regarding the authenticity of a communication alleged to have been made by or on behalf of Medtronic, please contact us immediately at [email protected].
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.
Pay range / Rango salarial / Intervalo salarial /Fascia retributiva / Tranche de salaire / Gehaltsband / Salaribereik: Netherlands: 47,680.00 EUR - 71,520.00 EUR |
This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).