Our client is at the forefront of personalized medicine, developing cutting-edge Next-Generation Sequencing (NGS) software and AI-native diagnostic platforms designed to democratize advanced cancer care globally. This position is 100% remote from anywhere in Spain. The Role As a Senior QARA Specialist, you will bridge the gap between strict regulatory compliance and fast-paced software development. You will play a key role in maintaining their Quality Management System and driving regulatory pathways for cutting-edge Software as a Medical Device and In Vitro Diagnostics. Key Responsibilities: * Develop and maintain a QMS that aligns with industry requirements and best practices. * Develop documentation processing and creation automation within the relevant compliance frameworks. * Stay updated with relevant regulations and standards in the industry such as IVDR, ISO 13485, ISO 27001 and GDPR, ensuring process compliance. * Support and manage timely responses to nonconformities, deviations, and other issues including implementing corrective and preventive actions.



* Oversee document control processes to ensure the accuracy, completeness, and accessibility of all quality-related documentation. * Collaborate with teams to develop and deliver quality-related training programs, fostering a culture of quality awareness and continuous improvement. * Work closely with suppliers to establish and maintain quality agreements, monitor supplier performance, and ensure the quality of products and services. * Work closely with R&D; on device roadmaps and overall D&D; process including Design & Development File creation and maintenance. * Work closely with Operations on product configuration and documentation, including product identification and traceability (UDI). * Lead initiatives to identify and implement process improvements across all aspects of internal operations. * Manage internal and external audits independently, including ISO 13485 and ISO 27001 audits. * Manage a robust

📌 Senior QARA (Álava)
🏢 Randstad España
📍 Álava