Senior Quality Systems Specialist
We are looking for an experienced customer focused team player that is very pro-active and naturally taking ownership. You will be working under limited supervision.
Besides the ability to independently manage multiple tasks you dispose of good problem-solving skills with critical thinking/decision skills and a high attention to detail and accuracy.
You are a good communicator and fluent in English, both in writing and speaking, to be able to act as professional liaison for various internal and external stakeholders.
Must Haves:
- Bachelor or master’s degree;
- At least 5 years of experience in a Quality/Regulatory function with a demonstrated focus on Quality Management Systems based on the medical device industry standard ISO13485;
- Demonstrated MDSAP and in particular FDA Quality System Regulation (21CFR Part820) knowledge and experience.
Nice to haves:
- Knowledge of Medical Device Regulation (EU) 2017/745 is a strong advantage;
- Knowledge of Canadian Medical Devices Regulations (CMDR) is a strong advantage;
- Lead auditor certification is a strong advantage.
About Medtronic
As a global leader in medical technology, services and solutions, Medtronic improves the health and lives of millions of people each year. We believe our deep clinical, therapeutic and economic expertise can help address the complex challenges - such as rising costs, aging populations and the burden of chronic disease - faced by families and healthcare systems today. But no one can do it alone. That’s why we’re committed to partnering in new ways and developing powerful solutions that deliver better patient outcomes.
Founded in 1949 as a medical repair company, we're now among the world's largest medical technology, services and solutions companies, employing more than 85,000 people worldwide, serving physicians, hospitals and patients in over 155 countries. With our European Operations Center for Distribution and Shared Services in Heerlen, the Bakken Research Center in Maastricht, our manufacturing facility in Kerkrade, and the Medtronic Eindhoven Design Center and Dutch sales office in Eindhoven, Medtronic Netherlands has more than 1,500 employees.
Whatever your specialty or ambitions, you can make a difference at Medtronic - both in the lives of others and your career. Join us in our commitment to take healthcare Further, Together.
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
