2 beste vacatures voor de functie van biomedical engineering in arnhem, ge (nieuwe medewerkers gezocht)

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

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Microbiologisch Analist
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Het pakket aan microbiologische analyses bestaat onder andere uit het uitvoeren van bioburden testen, steriliteitstesten, groeipromotietesten en identificatie…
Snel solliciteren
11 dagen

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QA/RA Specialist

Eurotrol -
Ede

Nu solliciteren

Vacaturegegevens

Fulltime

Kwalificaties

Engineering
Biomedische technologie
Master
Analytisch vermogen
Kwaliteitsborging
Bachelor

Volledige vacaturetekst

Ede
The Netherlands

Quality Assurance

Full-time

Your Role

As a QA/RA Specialist, you are an all‑round contributor within our QA/RA team. In this position, your primary focus lies on document management, CAPA, and product registrations. You play an active role in maintaining a compliant Quality Management System (QMS) by managing controlled documentation, handling quality issues through CAPA, and supporting regulatory registrations for our In‑Vitro Diagnostic Medical Devices. You work closely with internal stakeholders and external partners to ensure accuracy, traceability, and regulatory compliance.

Your Responsibilities

Manage, store, and track controlled quality documents and records within the QMS
Ensure documents are accurate, complete, and compliant with regulatory and internal requirements
Process documents for review, revision, approval, and controlled release
Coordinate document changes and ensure correct version control and distribution
Archive obsolete or inactive documents in accordance with retention requirements
Initiate, manage, and follow up on CAPAs, including root cause analysis and trend monitoring
Support the investigation and documentation of quality issues and non‑conformities
Maintain product registrations and registration-related documentation
Liaise with OEM manufacturers, distributors, and regulatory authorities
Support regulatory submissions and product changes

Education & Experience

Bachelor’s or Master’s degree in Life Sciences, Biomedical Engineering, Regulatory Affairs, or a related field
2–4 years of relevant experience in QA/RA within medical devices or IVD
Hands‑on experience with document control and CAPA processes
Familiarity with ISO 13485 and medical device regulations (IVDR preferred)
Experience with regulatory submissions and interactions with authorities is an advantage
Strong analytical, communication, and organizational skills

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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biomedical engineering vacatures in arnhem, ge

QA/RA Specialist

Senior QA/RA Specialist

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Ik wil de nieuwste vacature-alerts ontvangen voor de functie van biomedical engineering in arnhem, ge

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