Quality Assurance Specialist (interim, 12 months)

Quality Assurance Specialist (interim, 12 months) - Unity Partners - Vacatures

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.

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.

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.

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.

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 [staat bij de werkgever]

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