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)