Senior QA Lead - Clinical Software

Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters are in Barcelona, Spain and our Technology Centers are located in the United States and Europe. Worldwide sales exceeded €2.2 billion in 2024, and our workforce is more than 7,000 strong. JOB SUMMARY Solutions QA Leader focuses on organizational aspects of quality management, aiming to improve the end-to-end product development life cycle, from requirements analysis to launch and maintenance, including providing inputs and active contributions to the definition and maintenance of the Quality Management System (QMS). Working closely with the Solutions Leaders to ensure to deliver software releases with an ever-increasing level of quality. When applicable, QA Customer Liaison facilitating effective communication and understanding of QA processes, methodologies, and outcomes. KEY ACCOUNTABILITIES · Cooperating with the Director of Quality & Regulatory Affairs - Digital Solutions to co-ordinate quality assurance activities for all SW development products assigned. · Responsible for ingraining quality as a core discipline into every aspect of the SW development teams (Squads) organizations. · Ensure that SW Development teams (Squads) are informed with the perspective of the QA processes and/or customer requirements enabling the delivery of a product or service to an agreed level of quality. · Oversee SW project documents subject to QA approval ensuring the establishment and adherence to the appropriate QMS and customer processes and procedures, including but not limited to requirements management, configuration control, secure design, risk analysis, verification and validation, traceability, etc. · Support Change Management Board (CRB) process as needed. · Advance metrics and the setting of goals that provide visibility and understanding of development effectiveness from a quality perspective. · Drive Promote continuous improvement initiatives to enhance product quality, operational efficiency, and customer satisfaction. · Collaborate in the QS software development life cycle procedures definition and maintenance. Provides input in the implementation of the process. · Point of contact for the different business unit's / client related with Quality agreements · Take an active role in the training and dissemination of knowledge regarding quality system procedures. · Pursuing a unified approach to quality process implementation throughout the software development lifecycle across all solutions within a Factory. · Participate in software products audits and assessments as needed. NETWORKING/ KEY RELATIONSHIPS The main relationships within the Werfen Group are: · Factory Lead and…