Quality Assurance & Regulatory Affairs Manager
Are you looking for a challenging QA/RA position in an innovative high tech medical device company? Does overall quality management, implementing new products and ramping up production excite you? Then this is the job for you!
At Fortimedix Surgical we view quality as a shared responsibility across all disciplines. With over 20 years of experience in medical device development and manufacturing, including ISO 13485:2016 certification, CE-registration and FDA product clearance we created a strong track record in proving this vision.
We are looking for a QA/RA-manager that embraces our vision and is capable of engaging others. A person that takes responsibility and achieves results by taking process owners and the product and process developers along.
Your job will have a very broad scope, including activities such as audits, continuous improvement projects, change control and training to improve and maintain the quality management system. To keep our business processes compliant, you will collaborate with process owners and other stakeholders and provide them with advice and support. You drive measurement and monitoring processes in order to assure effective management reporting and manage software applications such as the document management system. To keep up with changing regulatory requirements, you will work in close collaboration with external regulatory consultants. Continuous improvement and operational excellence are important themes in your job.
You are an autonomous, independent thinker that is capable of effectively interacting with colleagues, customers, consultants and regulatory bodies in a natural way. You oversee the big picture and you are capable of streamlining and linking processes across disciplines. You maintain a healthy balance between ‘control & correct’ vs. ‘train & prevent’. You are accurate and strict while staying engaging and collaborative. As an experienced professional, you have a thorough understanding of laws and regulation. With your hands-on, proactive and collaborative personality, you fit the Fortimedix pioneering culture.
Qualifications & competencies
- Master degree in business administration, engineering or similar;
- At least 5 years of experience in the medical device industry;
- Understanding of both the EU and US quality system requirements ISO 13485 and 21 CFR Part 820;
- Experience with Quality System management, audits and document review;
- Fluent communication skills in English and preferably also in Dutch;
- ICT savvy.
A challenging job in an inspiring and rapidly developing high-tech company, where an open, professional and pleasant working culture is one of our most important assets. We embrace initiatives, ownership and a strong team spirit. By providing freedom, we support you to be creative and to organize the job in accordance with the overall goals of Fortimedix Surgical. We are committed to support your professional and personal development and give you the opportunity to cooperate with talented people.
Please submit your motivation and resume via the application form below, or contact human resources via firstname.lastname@example.org. If you have any questions regarding this vacancy or the applying procedure in general, please contact Ezra Erens (HR Director): +31 (0)6 21206133.
Our preference is given to applicants residing within a 90 km radius of Geleen, the Netherlands. If an applicant resides outside of this radius and accepts the job, we expect that he or she is willing to relocate to a residence within a 90 km radius of Geleen.