Quality Assurance Manager

Unity Partners exclusively on behalf of our MedTech AI partner

We have been retained by a fast-growing digital health scale-up in their search for a QA Manager with the ambition to grow into the Head of Quality position. This company develops an AI-powered CE-marked medical device with a user base all over the world. Quality and compliance are not an afterthought here; they are built into the product from day one.

The role comes with a clear growth trajectory: within roughly a year, the expectation is that you take full ownership of the Quality function.

Role Overview

As QA Manager you are responsible for the QMS and act as the go-to person on all quality and compliance topics. This is a SaMD environment, which means your work covers not just classic medical device quality but also software lifecycle management, algorithm quality, cybersecurity and data privacy.

Key Responsibilities

• Keep the QMS fit for purpose and audit-ready across EU MDR, MDSAP and FDA frameworks
• Run internal and external audits, drive CAPA resolution and keep complaint handling on track
• Manage document control, training compliance, supplier oversight and management reviews
• Apply relevant software and risk standards (ISO 14971, IEC 62304, IEC 62366) across design controls and V&V
• Maintain the ISMS and ensure ongoing compliance with ISO 27001, NEN 7510 and GDPR
• Keep technical documentation, product release and post-market surveillance in good shape
• Work closely with Regulatory, Product, Clinical and Operations to make quality part of how the business operates
• Play a key role in the transition from the current QMS setup toward a future eQMS

Your Profile

• 5+ years in medical device QA, with a strong preference for SaMD, AI or digital health backgrounds
• Familiarity with AI/ML in a regulated context is a real plus
• Comfortable growing into a team lead role within about a year
• Solid working knowledge of ISO 13485, EU MDR, MDSAP, FDA 21 CFR Part 820, and the relevant software standards
• Experience with information security compliance and GDPR in practice
• You build structure without slowing things down
• Fluent in English; Dutch is a plus
• Regular on-site presence is part of the role

A role with real ownership and a clear path to Head of Quality. Direct impact on a product that improves early detection of serious disease. Informal, international team with short lines and genuine ambition. Hybrid working from the Randstad, competitive salary, 25 holidays and development budget.