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)
&##127757; 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.
&##128295; 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
&##127891; 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)