2 beste vacatures voor de functie van qa/ra specialist in driebergen rijsenburg, ut (nieuwe medewerkers gezocht)

Senior QA/RA Specialist
Eurotrol —Ede
- Fulltime
- Engineering
- Master
QA/RA Specialist
Eurotrol —Ede
- Fulltime
- Engineering
- Master
- Analytisch vermogen

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Senior QA/RA Specialist
Eurotrol —Ede
You support product development, ensure regulatory compliance, lead audits and complex CAPAs, and actively contribute to continuous improvement of the QMS.
QA/RA Specialist
Eurotrol —Ede
Ensure documents are accurate, complete, and compliant with regulatory and internal requirements. In this position, your primary focus lies on document…

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Senior QA/RA Specialist

Eurotrol -
Ede

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Vacaturegegevens

Fulltime

Kwalificaties

Engineering
Biomedische technologie
Master
Kwaliteitsborging
Productontwikkeling

Volledige vacaturetekst

Ede
The Netherlands

Quality Assurance

Full-time

Your Role

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

Education & Experience

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

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

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qa/ra specialist vacatures in driebergen rijsenburg, ut

Senior QA/RA Specialist

QA/RA Specialist

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Ik wil de nieuwste vacature-alerts ontvangen voor de functie van qa/ra specialist in driebergen rijsenburg, ut

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