QA Specialist

Our client, a fast-growing MedTech start-up specializing in surgical software, is seeking a professional to lead their quality initiatives. This role focuses on building a robust quality management system from the ground up and preparing for upcoming regulatory submissions.

• Establish and maintain a comprehensive Quality Management System (QMS) from scratch.
• Coordinate and prepare documentation for upcoming regulatory submissions.
• Ensure software development processes comply with industry-specific quality and safety standards.
• Implement a risk-based quality approach within a fast-paced environment.
• Maintain and update quality records with a high level of detail and accuracy.
• Support cross-functional teams in integrating quality procedures into daily operations.

• You have 2+ years of experience in quality assurance or regulatory affairs within the medical device industry.
• You possess practical experience in setting up and managing a QMS according to ISO 13485.
• You bring a proactive, independent, and detail-oriented mindset with the ability to adapt to a start-up environment.
• You are fluent in English and Dutch.

Nice to Haves

• Experience with IEC 62304, FDA regulatory pathways, and EU MDR.
• Willingness to obtain knowledge in ISO 14001 or experience with sustainability legislation.

• 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.