Design Quality Engineer (DQE) - Medical Devices - Belgium - Contract

We are seeking a Design Quality Engineer (DQE) to support R&D teams in transitioning from non-medical to medical device development. This role is critical in ensuring compliance with medical device regulations ( ISO 13485, 510K, IEC 62304, risk management, usability, clinical evaluation ) for key projects. Reporting to the PMO Lead, you will play a key role in technical file development, regulatory alignment, and cross-functional facilitation.

Key Responsibilities

• Develop and maintain technical files for medical device projects.
• Collaborate with project managers, software architects, security teams, and usability engineers.
• Act as a liaison between R&D and QARA teams, ensuring regulatory clarity.
• Coach and mentor teams on best practices in IEC 62304 and related standards.
• Identify gaps in compliance processes and drive improvements.
• Support audits by ensuring documentation is complete and audit-ready.
• Develop training programs to enhance R&D’s regulatory knowledge.

Required Qualifications

• Proven experience in developing technical files for medical devices .
• Strong knowledge of ISO 13485, 510K, IEC 62304, and risk management .
• Excellent communication and facilitation skills for cross-functional collaboration.
• Ability to coach and mentor teams to improve compliance and documentation quality.
• Strong problem-solving and analytical skills to identify and address process gaps.
• Attention to detail to ensure accuracy in technical documentation.

Why Join Us?

• Be part of an impactful R&D team working on cutting-edge medical devices .
• Work in a dynamic cross-functional environment with technical experts.
• Opportunity to drive quality and compliance in medical device innovation.

📩 Apply now to contribute to the future of medical technology!