Quality Engineer (Medical Devices / AI Healthcare)Industry: Healthcare/Medical DevicesLocation: Belgium (Hybrid)Language: English (working language)Salary: Up to €65,000 gross annually (depending on experience)
About the RoleAre 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 ResponsibilitiesQuality Management System (QMS)Support and strengthen the QMS in line with FDA 21 CFR Part 820 and ISO 13485Help develop, review, and maintain quality documentation including SOPs, work instructions, and recordsEnsure proper document control and traceability across processes
Design Controls & Product QualitySupport design control activities in accordance with medical device regulationsMaintain traceability matrices linking requirements, risks, verification, and validationAssist with Verification & Validation (V&V) activities and documentation
CAPA & ComplianceSupport CAPA processes, nonconformance investigations, and structured root cause analysisContribute to continuous improvement initiatives across quality and operational processesAssist in preparing for and supporting internal audits and regulatory inspections
Cross-Functional CollaborationWork closely with Engineering, Manufacturing, Clinical, and Regulatory teamsProvide quality guidance during product development and lifecycle managementHelp ensure compliance throughout product development and post-market activities
Profile & ExperienceBachelor's or Master's degree in Engineering, Life Sciences, Biomedical Engineering, or related field2+ years of experience in a regulated medical device or healthcare environmentStrong understanding of ISO 13485 and FDA 21 CFR Part 820Experience with design controls, CAPA, risk management (ISO 14971 is a plus)Analytical mindset with structured problem-solving skillsFluent in English (company working language)