Quality Engineer (Medical Devices / AI Healthcare) Industry: Healthcare/Medical Devices Location: Belgium (Hybrid) Language: English (working language) Salary: Up to €65,000 gross annually (depending on experience) 🌍 About the Role Are you passionate about quality, compliance, and continuous improvement in a regulated environment? Do you want your work to directly support innovative medical technology that improves patients’ lives? As a Quality Engineer, you will play a key role in maintaining and strengthening the Quality Management System (QMS) that supports cutting-edge AI-driven neurological imaging solutions. Your work will ensure compliance with FDA and ISO standards while contributing to products that have real-world clinical impact. 🔧 Key Responsibilities Quality Management System (QMS) Support and strengthen the QMS in line with FDA 21 CFR Part 820 and ISO 13485 Help develop, review, and maintain quality documentation including SOPs, work instructions, and records Ensure proper document control and traceability across processes Design Controls & Product Quality Support design control activities in accordance with medical device regulations Maintain traceability matrices linking requirements, risks, verification, and validation Assist with Verification & Validation (V&V) activities and documentation CAPA & Compliance Support CAPA processes, nonconformance investigations, and structured root cause analysis Contribute to continuous improvement initiatives across quality and operational processes Assist in preparing for and supporting internal audits and regulatory inspections Cross-Functional Collaboration Work closely with Engineering, Manufacturing, Clinical, and Regulatory teams Provide quality guidance during product development and lifecycle management Help ensure compliance throughout product development and post-market activities 🎓 Profile & Experience Bachelor’s or Master’s degree in Engineering, Life Sciences, Biomedical Engineering, or related field 2+ years of experience in a regulated medical device or healthcare environment Strong understanding of ISO 13485 and FDA 21 CFR Part 820 Experience with design controls, CAPA, risk management (ISO 14971 is a plus) Analytical mindset with structured problem-solving skills Fluent in English (company working language)