We’re looking for a Senior QA Engineer to expand the team of a HealthTech project in the Netherlands. The project is an AI-powered platform for emergency stroke diagnosis. It uses artificial intelligence to analyze 3D CT scan images in less than 3 minutes, enabling doctors to make immediate, life-saving decisions. As Quality Engineer, you will oversee and ensure the compliance of software development processes, including software releases. You will be key in continuously improving existing and new processes, introducing efficiencies and optimizing workflows.
Requirements: * 4+ years of experience in Quality Assurance Engineering. * Strong passion for software quality and continuous improvement of compliant development practices across the product and organization. * Experience working within an ISO 13485-compliant Quality Management System (QMS). * Solid knowledge of ISO 14971 and ISO 62304; familiarity with MDR is a strong advantage. * Ability to establish and maintain regulatory compliance while keeping the QMS efficient, scalable, and adaptable to company growth. * Comfortable working in a fast-paced startup environment with evolving goals and structure. * Ability to balance commercial needs with high-quality standards. * Broad interest in software quality, performance, safety, and regulatory compliance. * Strong ownership mindset with proactive communication across teams and stakeholders. * English level: Upper-Intermediate or higher.
Responsibilities: * Lead and support Quality Management System (QMS) processes within software development and product release cycles. * Oversee risk management activities for software products. * Provide training and guidance to engineering teams on QMS processes and compliance standards. * Manage error monitoring, escalation processes, and hotfix coordination. * Drive engineering Non-Conformities (NCs) and Corrective and Preventive Actions (CAPAs). * Plan and execute release testing, including test development, updates, automation, and validation. * Maintain and support non-medical device quality processes. * Support medical device product development, including testing, requirements management, risk management, and preparation of regulatory documentation (architecture documentation, technical files, and submission materials). * Provide support during internal and external QMS audits. * Develop, document, and automate workflows in Jira. * Perform QMS software validation activities to ensure regulatory compliance.
We offer: * Competitive salary. * Challenging tasks and projects. * Opportunities for professional development and growth. * Flexible working hours. * New hardware. * Free English lessons. * Table tennis and yoga classes. * Availability of generators and Starlinks in the office. * Small gym in the office. * Adjustable height tables. * Regular office fruit delivery and other benefits.
