Design Quality Engineer

Design Quality Engineer

Belgium | 40 Hours per Week | Hybrid (2-3 Days On-Site)Target Start Date: January 2027

We're partnered with an innovative medical device company developing highly regulated implantable technology used in critical healthcare applications. Due to continued growth, they are seeking a Design & Development Engineer to support product development and technical documentation activities across the full product lifecycle.

This is an excellent opportunity for someone with experience in medical device documentation, quality, design controls, or regulatory compliance who wants to work on complex Class II/III products within a collaborative and fast-growing environment.

Key Responsibilities

• Review and assess technical documentation from external development partners and suppliers.
• Ensure documentation aligns with FDA 21 CFR Part 820, EU MDR (2017/745), and ISO 13485 requirements.
• Identify documentation gaps and work with external partners to resolve deficiencies.
• Maintain and update Design History Files (DHF), Technical Documentation (TD), and Manufacturing Documentation Files (MDF).
• Support design control activities, including traceability, verification, validation, and risk management documentation.
• Assist with clinical investigation documentation and product development activities.
• Work closely with Quality, Regulatory Affairs, Manufacturing, and Development teams.
• Support audits, CAPAs, NCRs, and other Quality Management System activities.
• Contribute within a small, agile team where flexibility and ownership are highly valued.

Requirements

• Bachelor's or Master's degree in Engineering, Biomedical Engineering, Life Sciences, or a related technical discipline.
• 2-5 years of experience within Medical Devices, preferably in Design & Development, Design Assurance, Quality, Regulatory Affairs, or Technical Documentation.
• Experience with:
• Design History Files (DHF)
• Technical Documentation / Technical Files
• ISO 13485
• EU MDR 2017/745
• FDA 21 CFR Part 820
• Understanding of Design Controls and Product Development processes.
• Familiarity with Risk Management (ISO 14971) and Verification & Validation activities.
• Strong document review, technical writing, and stakeholder management skills.
• Experience with implantable, active, or Class II/III medical devices is highly desirable.
• Dutch language skills are advantageous but not essential.

What's on Offer

• January 2027 start.
• Hybrid working model (2-3 days on-site).
• Exposure to innovative, highly regulated medical device technology.
• Opportunity to work across R&D, QA/RA, Clinical, and Manufacturing functions.
• Significant career development within a growing international organisation.

Desired Skills and Experience

Design & Development, Design Assurance, Design Controls, DHF, Technical Documentation, Technical File, MDR, ISO 13485, FDA 21 CFR 820, ISO 14971, Verification & Validation, V&V, Risk Management, Regulatory Affairs, Quality Engineering, Medical Devices, Class II, Class III, Implantable Devices.