In this role you’ll represent the QA/RA department in the process of model- and software development and play an important role in software implementation from the QA/RA perspective.
- Manage the process of design changes and the implementation of these changes according to agreed timelines and document evidence for safety and compliance
- Perform root cause analysis and problem solving in complaint handling
- Be a member of the internal audit team and support the quality manager to complete the internal audit program according to planning
- Participate as a trainer in QMS training sessions like CAPA and complaint handling
- Be involved in moderate risk management and review software validation tests
- Actively monitor developments in the regulatory field
- Preferably a Master’s degree in a relevant area
- At least 3 years’ experience in QA Medical Devices. Experience with a software is a plus
- Familiar with ISO13485 and MDR
- Excellent English verbal and written skills
- Good communicator, analytical skills, ambitious and motivated attitude
ORGANISATION AND OFFER
This organisation is creating a healthcare system where all patients get the best possible treatments. Personalized care where professionals learn from at the same time.
You’ll work in a growing and vibrant environment, dedicated to making health care smarter and better. They offer a competitive salary and benefits. Besides that, a lot of opportunity for personal development and to become part of the employee participation plan.
INTERESTED? Reach out to Christian Steenkamp for more information by contacting +31 (0)20 20 44 502 or firstname.lastname@example.org