QA/RA Specialist

Your Role

Do you thrive in a dynamic environment where regulations meet innovation? As an all-round QA/RA Specialist, you will join a committed QA/RA team (8 colleagues strong) and play a key role in maintaining and enhancing the quality and regulatory standards of our In-Vitro Diagnostic Medical Devices.

Together with the team, you'll:

• Support product development and product change processes—from design transfer to implementation
• Maintain and update quality processes, ensuring continued compliance and operational excellence
• Support the controlled release of documents by managing document control processes
• Contribute to CAPA management, root cause analysis, and trend monitoring
• Register new products and liaise with OEM manufacturers, distributors, and global authorities
• Actively participate in internal and external audits

What You Bring

• A completed HBO or WO degree
• A curious, proactive, and solution-oriented mindset
• Self-discipline, organization, and a keen eye for detail
• Eagerness to learn, grow, and collaborate
• Proficiency in both Dutch and English (written & verbal)
• Preferably: 1–3 years of QA/RA experience in a medical device or IVD environment
• Preferably: familiarity with international quality standards and regulatory guidelines

Why Join Us?

• A vital role in a healthy and future-focused organization
• Clear growth paths via personalized competence development models
• Opportunities to innovate and make real impact on safer healthcare
• A positive work culture that encourages initiative and knowledge sharing
• Market-competitive salary and a dynamic, flexible work environment