QA Specialist – Global Responsibilities

Location:

Wageningen – Gelderland, Nederland, Netherlands

Salary:

Negotiable

Type:

Permanent

Main Industry:

Search Science Jobs

Other Industries & Skills:

Chemistry, Physics, Life s

Advertiser:

NonStop Consulting

Job ID:

132454976

Posted On:

18 November 2025

Your Role: QA Specialist

Are you looking to grow into a true QA/RA Specialist all-rounder within an international and fast-moving environment? In this position, you’ll join a close-knit QA/RA team and contribute directly to the quality and regulatory foundation behind a global portfolio of In-Vitro Diagnostic devices.

This is a hands-on role where you will work on a wide variety of topics – from quality processes and documentation to CAPA, change control and supporting product registrations (around 100 per year). You’ll collaborate with international partners, work with complex systems, and gain exposure to global regulatory frameworks including ISO 13485, MDR/IVDR and MDSAP.

You will:

Support quality processes, document control, and change management
*

Contribute to CAPA investigations, root cause analysis, and trend monitoring
*

Assist with product registrations and communication with external partners
*

Help ensure QMS compliance and participate in internal/external audits
*

Collaborate closely with R&D, Operations, and Regulatory teams
*

Grow into a broad QA/RA role with both technical and regulatory exposure

This is a fully on-site position (0 remote days), with flexible start times between 07:00-09:00. Occasional homeworking can be discussed but is not standard.

What You Bring

A completed HBO/WO degree
*

Ideally 4-10 years of experience across QA and/or RA
*

Experience with CAPA, QMS processes, document control, change control
*

RA experience is a plus (registrations, submissions) but not required
*

Knowledge of ISO 13485 and MDR/IVDR; MDSAP exposure is a strong advantage
*

A practical, hands-on mindset with strong sense of ownership
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A collaborative, open personality – someone who supports the team and isn’t afraid to reach out
*

English is sufficient; Dutch is not required

Why Join

Become a true QA/RA all-rounder with exposure to many different projects
*

Strong learning curve in a complex, global environment
*

Work with colleagues around the world
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Flat structure with room for contribution and initiative
*

Stable, growing organization with an international footprint

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