As a Senior QA/RA Specialist, you act as a subject matter expert and strategic partner within the organization. You support product development, ensure regulatory compliance, lead audits and complex CAPAs, and actively contribute to continuous improvement of the QMS. You play a key role in guiding quality and regulatory decisions and supporting the professional development of other QA/RA team members.
Your Responsibilities- Support product development, design transfer, and complex product changes
- Interpret and apply regulatory requirements (including IVDR) across the organization
- Lead and assess complex CAPAs, including effectiveness checks and trend analyses
- Prepare for, support, and participate in internal and external audits
- Drive continuous improvement initiatives within the QMS
- Coach and mentor junior and medior QA/RA colleagues
- Provide strategic input on quality and compliance topics
- Master’s degree in Life Sciences, Biomedical Engineering, Regulatory Affairs, or a related discipline
- 4+ years of experience in QA/RA within the medical device or IVD industry
- Proven experience supporting product development and regulatory compliance
- Strong knowledge of ISO 13485, IVDR, and audit practices
- Demonstrated experience leading CAPAs and audits
- Ability to work independently, influence stakeholders, and provide expert guidance
- A vital role in a healthy and future-focused organization
- 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
Salarisomschrijving
€60000 - €80000 monthly