Summary
✨ AI‑Generated
A quality engineering position supporting investigations, corrective actions, audits, documentation, and regulatory activities within a regulated technology environment.
Highlights
Hands-on quality engineering role with broad responsibilities, involvement in compliance activities, and exposure to regulated products.
Description
Unity Partners exclusively on behalf of our MedTech partner
QA/RA Engineer
Our partner is a MedTech manufacturer dedicated to delivering high-end solutions in the field of radiotherapy, with products used by hospitals and clinics worldwide.
With a close-knit and experienced team, they combine a strong focus on quality, safety, and innovation with a hands-on and informal culture.
To strengthen their QARA team, we are looking for a QARA Engineer with an engineering background who can take on a varied, operational role with a primary focus on complaint handling.
Role Overview
As QARA Engineer, you support the QARA 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 organisation and real variety from day one.
This is a 1-year contract with hybrid working: minimum two days per week in the office, with Tuesdays preferred.
Key Responsibilities
Lead assigned complaint investigations and support related product investigation mattersContribute to CAPA and non-conformance investigationsPerform internal and supplier auditsContribute to revising and releasing QMS documentsSupport product registrations in various countriesEnsure compliance with FDA 21 CFR Part 820, EU MDR 2017/745 and ISO 13485
Your Profile
Bachelor's or Master's degree in Mechanical, Industrial, Biomedical Engineering or a related technical field1 to 3 years of experience in quality assurance, complaint handling or a related role; junior candidates and recent graduates are also welcome to applyPragmatic, calm, precise and focused on getting work doneExperience with FDA, MDR, ISO 13485 or ISO 14971 is a bonus, not a requirementExcellent written and verbal communication skills in English; Dutch is a plus
What is on offer
A varied, hands-on role with direct impact on patient safety and regulatory complianceClose-knit team with short reporting lines and genuine flexibilityGood salary aligned with experience, up to €4.250 per month25 vacation days and a solid pension schemeHybrid working with a good work-life balance1-year contract with potential for extension
Interested?
Reach out to Christian Steenkamp via christian@unitypartners.nl | +31 (0)20 8938 606
