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 RoleAs 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 risk management

📌 Senior Qara (Vitoria-Gasteiz)
🏢 Randstad España
📍 Vitoria-Gasteiz