Quality Assurance Specialist (interim, 12 months)

Unity Partners exclusively on behalf of our MedTech partner

Interim Quality Assurance Specialist – Medical Device Development | Haarlem (Hybrid)Duration: 12 months

Our partner is a fast-growing MedTech company developing next-generation medical devices in a regulated environment. To strengthen their Quality function during an important phase of product development and scale-up, we are seeking an experienced Interim QA Specialist for a 12-month engagement.

Role Overview

In this hands-on interim role, you will play a central part in building and embedding an ISO 13485–compliant Quality Management System across design, development, and manufacturing activities. Working at the intersection of R&D and Operations, you will ensure that quality, risk management, and regulatory requirements are integrated throughout the full product lifecycle — from early-stage development through to production readiness.

Key Responsibilities

• Build and continuously improve the ISO 13485 QMS in an early-stage development context.
• Embed design controls, risk management (ISO 14971), and change control processes.
• Act as a quality partner to R&D and Manufacturing during development and scale-up phases.
• Drive supplier qualification, conduct audits, and establish quality agreements.
• Manage CAPA, deviation, and complaint handling processes.
• Support FDA and EU MDR compliance activities as required.
• Apply IEC 62304 across the software development lifecycle, including requirements, design, verification, and validation.
• Prepare for and facilitate internal and external audits.
• Enable a smooth and controlled transition from development to full-scale production.

Your Profile

• Bachelor's or Master's degree in Life Sciences, Engineering, or a related field.
• Solid track record in Quality Assurance within the medical device industry.
• In-depth knowledge of ISO 13485; working knowledge of FDA regulations and/or EU MDR is an advantage.
• Familiarity with IEC 62304 for medical device software lifecycle management.
• Experience in a start-up or small R&D team environment is a strong plus.
• Pragmatic and structured — at ease in a fast-paced, innovation-driven environment.
• Strong communicator with a natural ability to collaborate across disciplines.
• Fluent in English; Dutch is a plus.

Assignment & Offer

• 12-month interim assignment with immediate impact.
• Hybrid working arrangement based in the Amsterdam area.
• Competitive day rate, commensurate with experience.
• Meaningful role with direct influence on product quality, compliance, and go-to-market readiness.

Interested?Reach out to Christian Steenkamp at christian@unitypartners.nl

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