A medical technology company is looking for a QA/RA Engineer. This company delivers high-end solutions in the field of radiotherapy, with products used by hospitals and clinics worldwide. The team combines a strong focus on quality, safety, and innovation with a hands-on and informal culture.
What you do
As a QA/RA Engineer, you support the QA/RA team across complaint investigations, CAPAs, and non-conformities, bringing an engineering perspective to the work. Beyond complaints, you contribute to internal audits, QMS document revisions, and product registrations in new and existing markets. This is a hands-on role with broad visibility across the organization and real variety from day one.
- Lead assigned complaint investigations and support related product investigation matters
- Contribute to CAPA and non-conformance investigations
- Perform internal and supplier audits
- Contribute to revising and releasing QMS documents
- Support product registrations in various countries
- Ensure compliance with FDA 21 CFR Part 820, EU MDR 2017/745, and ISO 13485
Profile
- Bachelor's or Master's degree in Mechanical, Industrial, Biomedical Engineering, or a related technical field
- 1 to 3 years of experience in quality assurance, complaint handling, or a related role; junior candidates and recent graduates are also welcome to apply
- Pragmatic, calm, precise, and focused on getting work done
- Experience with FDA, MDR, ISO 13485, or ISO 14971 is a bonus, not a requirement
- Excellent written and verbal communication skills in English; Dutch is a plus
What they offer.
- A varied, hands-on role with direct impact on patient safety and regulatory compliance
- A close-knit team with short reporting lines and genuine flexibility
How to apply
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