RA/ QA Specialist

Location Amsterdam
Discipline: Medical Device
Job type: Permanent
Contact name: Christian Steenkamp

Contact email: c.steenkamp@panda-int.com
Job ref: 20139
Published: about 2 months ago
At this moment, I am looking for a RA/QA Specialist to join a dynamic MedTech scale-up in Amsterdam. This organisation is on an inspiring mission in the HealthTech industry and currently in an exciting phase of growth.
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.

MAIN RESPONSIBILITIES
  • 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

YOUR PROFILE
  • 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 c.steenkamp@panda-int.com