QA Specialist

Our client, a fast-growing MedTech organization, is seeking a professional to establish their quality foundations and guide their initial regulatory submission. This role focuses on building a robust quality framework for an innovative surgical software platform.

• Establish and implement a comprehensive Quality Management System from the ground up.
• Manage technical documentation and ensure compliance with medical device regulations.
• Support the preparation and execution of regulatory submissions for specialized software systems.
• Develop internal quality processes and streamline documentation workflows.
• Apply a risk-based mindset to quality oversight and operational decision-making.

• You bring 2+ years of experience in quality assurance or regulatory affairs within the medical device sector.
• You have practical experience setting up a Quality Management System based on ISO 13485.
• You possess a proactive, hands-on attitude and the ability to build processes independently.
• You're highly detail-oriented with a meticulous approach to documentation and compliance.
• You are fluent in English and Dutch.

Nice to Haves

• Experience with IEC 62304, EU MDR, or FDA regulatory pathways.
• Knowledge of sustainability legislation such as ISO 14001.

• Enjoy a competitive salary package with extra perks that recognize your talent.
• Advance your career with a clear growth path, coaching, and mentoring to support you.
• Thrive in a dynamic and supportive environment where you can truly make an impact.
• Work when and where you perform best, ensuring an optimal work-life balance.
• Choose a flexible transport solution, from a company car to a public transport subscription.
• Expand your network and enjoy unforgettable moments at exclusive events and afterworks.
• Grow your skills with external courses and our in-house Pauwels Academy.
• Work on exciting projects with industry leaders in Life Sciences, Engineering & Digital.
• Seize opportunities at every level, from a strong start to career acceleration and expert collaboration.