MedTech QA Engineer for AI/SaMD - Quality & Automation

PaHRtners

Luik

Sur place

EUR 55 000 - 85 000

Plein temps

Il y a 38 heures

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Résumé du poste

PaHRtners is seeking a Quality Assurance Engineer to join its Software, Digital & AI Team, ensuring quality, reliability and regulatory compliance of the company’s medical software throughout the product lifecycle.

You will develop verification strategies, drive test automation and collaborate with Product Management, Software Engineering, AI, Clinical and Regulatory teams to deliver high-quality solutions that support clinical decision-making and improve patient outcomes in a fast-paced MedTech

Qualifications

Bachelor's or Master's degree in Computer Science, Software Engineering, Biomedical Engineering or a related technical discipline.
ISTQB Foundation or Advanced Certification is desirable.
5+ years of experience in software QA, software verification or quality engineering.
Experience developing and executing manual and automated software testing within Agile development environments.
Experience with automated testing frameworks, CI/CD pipelines and defect management tools.
Experience designing test plans, test cases and verification protocols for software products.
Experience with SaMD, AI-enabled medical devices, digital pathology, or medical imaging is highly desirable; a strong willingness to learn the healthcare domain will also be considered.
Experience working within regulated environments (FDA, EU MDR, ISO 13485, IEC 62304 and ISO 27001) is an advantage.
Comfortable working in a fast-paced, innovative scale-up environment.
Excellent written and verbal English required; French would be an advantage.

Responsabilités

Develop and maintain comprehensive verification strategies, test plans and automated test frameworks covering functional, integration, regression, performance and end-to-end testing.
Integrate automated testing into CI/CD pipelines to enable continuous quality validation and improve software release efficiency.
Ensure software quality through exploratory testing, clinical workflow simulations and customer acceptance testing that reflects real-world use in surgical environments.
Ensure complete traceability between requirements, risks and verification activities while supporting design verification, validation, regulatory submissions and quality management system activities.
Work closely with Product Management, Software Engineering, AI and Clinical teams to identify, prioritize and resolve defects, support release readiness and continuously improve quality engineering practices across the Digital & AI organization.