Quality Engineer

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 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

Your 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 is on offer

• A varied, hands-on role with direct impact on patient safety and regulatory compliance
• Close-knit team with short reporting lines and genuine flexibility
• Good salary aligned with experience, up to €4.250 per month
• 25 vacation days and a solid pension scheme
• Hybrid working with a good work-life balance
• 1-year contract with potential for extension

Interested?

Reach out to Christian Steenkamp via christian@unitypartners.nl | +31 (0)20 8938 606