Quality Engineer – QARA (Regulatory & Quality Management)

About the role

As a Quality Engineer you will support the Design & Development and Quality department by planning, supervising and continuously improving the company’s quality and regulatory management systems. You will work closely with Business Engineers, UX/UI designers and developers to translate stakeholder requirements into user‑friendly solutions.

Key responsibilities

• Develop and maintain Quality Management Systems (QMS) and related SOPs.
• Implement performance measurement tools to ensure compliance with ISO 9001, ISO 13485 and other legal requirements.
• Plan, budget and monitor departmental activities, reporting any changes in standards or performance.
• Conduct QA checks on products and projects, and train staff on quality and regulatory procedures.
• Manage FDA‑related processes, RA compliance checks and regulatory files (e.g., ISO 14971, MEDDEV).
• Collaborate with managers to design and implement continuous improvement controls.

Required profile

• 1‑3 years of experience as a quality professional or a Master’s degree in a relevant field.
• Hands‑on experience with ISO 9001 and ISO 13485.
• Fluent English (written and spoken); Dutch is a plus.
• Motivated, team‑oriented and comfortable working in a fast‑paced, young environment.

Required skills

• ISO 9001 implementation
• ISO 13485 implementation
• FDA process management
• Regulatory affairs documentation (ISO 14971, MEDDEV)
• SOP authoring and QA inspection

What we offer

• Competitive salary and pension scheme
• Brand‑new laptop and remote‑work possibility (minimum 32 hours/week)
• Daily lunch, Beer O’Clock Fridays and a healthy work environment
• Opportunities to design the platform from scratch and grow your career