Interim Quality Assurance Specialist

Unity Partners exclusively on behalf of our MedTech partner

Interim Quality Assurance Specialist – Medical Device Development

Duration: 12 months

Our partner is an innovative MedTech company operating in a highly regulated environment. To support ongoing product development and scale-up activities, we are looking for an Interim Quality Assurance Specialist to strengthen the Quality function for a 12-month assignment.

Role Overview

As Interim Quality Assurance Specialist, you will support and maintain an ISO 13485–compliant Quality Management System during design, development, and manufacturing activities. You will work closely with R&D and Operations to ensure quality processes, design controls, and risk management are properly embedded across the product lifecycle.

Key Responsibilities

• Maintain and improve the ISO 13485 QMS.
• Support design controls, risk management (ISO 14971), and change control.
• Collaborate with R&D and Manufacturing during development and scale-up.
• Support supplier qualification, audits, and quality agreements.
• Manage CAPA, complaints, and deviations.
• Support FDA and EU MDR compliance activities where required.
• Prepare and support internal and external audits.

Your Profile

• Bachelor’s or Master’s degree in Engineering, Life Sciences, or similar.
• Proven experience in Quality Assurance within the medical device industry.
• Strong knowledge of ISO 13485; familiarity with FDA and EU MDR is a plus.
• Hands-on, structured, and comfortable in fast-moving development environments.
• Strong communication skills and ability to work cross-functionally.
• Fluent in English.

Assignment & Offer

• Interim assignment for 12 months.
• Hybrid working model (Hoofddorp area).
• Competitive interim rate, depending on experience.
• High-impact role with direct influence on product quality and compliance.

Interested?

Interested in a hands-on QA role within a MedTech development environment?
Contact Christian Steenkamp via christian@unitypartners.nl

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