Quality Assurance Manager

Unity Partners; Randstad; Hybrid; EUR 90,000 - 130,000; Full time

Benefits offered by this job

Hybrid working from Randstad

Development budget

25 holidays

Job summary

Unity Partners exclusively on behalf of our MedTech AI partner is seeking a QA Manager who will own the QMS and drive quality and compliance across the product lifecycle in a SaMD environment, including software lifecycle management, algorithm quality, cybersecurity and data privacy.

You will grow into a Head of Quality within about a year, work with an international team, and operate from the Randstad with hybrid arrangements.

Qualifications

• 5+ years in medical device QA, preferably SaMD or digital health.
• Familiarity with AI/ML in regulated environments is a plus.
• Willingness to grow into a team lead within ~12 months.
• Strong knowledge of ISO 13485, EU MDR, MDSAP, and FDA 21 CFR Part 820.
• Experience with information security and GDPR compliance.
• Able to deliver structure without slowing processes.
• Fluent in English; Dutch language is a plus.
• Willing to work on-site regularly.

Responsibilities

• Maintain QMS and audit readiness across EU MDR, MDSAP, and FDA.
• Lead internal and external audits, CAPA remediation, and complaints.
• Oversee document control, training compliance, supplier oversight, and management reviews.
• Apply software and risk standards (ISO 14971, IEC 62304, IEC 62366) in design and V&V.
• Maintain ISMS and ongoing ISO 27001, NEN 7510 and GDPR compliance.
• Keep technical documentation, product release, and post-market surveillance in shape.
• Collaborate with Regulatory, Product, Clinical, and Operations to embed quality.
• Guide transition from current QMS to future eQMS.

Skills

Medical device QA

AI/ML in regulated context

Team leadership readiness

ISO 13485

EU MDR MDSAP

FDA 21 CFR Part 820

Information security & GDPR

English fluency

On-site presence

Dutch language

Job description

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.