• Build an automation framework from scratch, starting with API-level coverage of critical end-to-end happy path flows, the ones that must never break in a product shipping multiple times a day. • Mentor QA team members into more technical and structured testing practice. • Work with developers to build shared ownership of quality across engineering: encourage better unit testing, help them understand what good coverage looks like, and shift quality from a QA concern to a team habit. • Run exploratory testing to surface edge cases and failure modes that specs don't anticipate. • Own feature aftercare: monitor releases in production, track stability, and drive continuous improvement from what you find. • Identify gaps that developers and PMs miss and bring them to the table early, contributing to product decisions throughout the cycle, not just at the end. • Track QA metrics that matter, bug detection rate, release confidence, post-release defect counts, and own the narrative around what they mean for the product.

• Prepare and manage regulatory and quality documentation for CE mark submission and Notified Body reviews. • Coordinate with technical, clinical and other teams, provide trainings and guidance, with support from external CE consultants. • Support the development and maintenance of the Quality Management System (QMS). • Support the preparation and upkeep of the Technical File, including collecting information, compiling evidence, drafting documentation, and collaborating closely with engineering, design, and data teams. • Assist with ISO certification activities (e.g., ISO 13485). • Maintain document control, records, logs, and change control to ensure audit readiness and ongoing compliance. • Act as the main point of contact for consultants and the Notified Body, drafting responses and scheduling audits. • Coordinate requirements, risk, usability, and verification evidence with product, design, and engineering teams. • Contribute to post-market surveillance activities after approval. • Track timelines, prepare status updates, and facilitate cross-team collaboration.

• Definir y ejecutar los requisitos de prueba para garantizar la calidad de las soluciones antes de su salida a producción. • Diseñar, revisar y ejecutar planes de pruebas manuales y automatizadas alineados con estándares de calidad y buenas prácticas del sector. • Identificar, registrar y hacer seguimiento de defectos, asegurando su correcta resolución junto a los equipos técnicos. • Colaborar activamente con desarrolladores, ingenieros y tech leads dentro de squads Agile. • Asegurar una experiencia de usuario óptima siguiendo el enfoque Think Customer en las soluciones de Contact Centre e IVR.

• Manage the supplier change notification lifecycle, including evaluation, risk assessment, approval, tracking, and closure. • Perform trend analysis of supplier quality data and proactively identify emerging risks. • Review, analyze, and report supplier trends, including effectiveness and sustainability of corrective actions. • Interface and collaborate with Supply Chain, Incoming Quality, Quality Assurance, Technical Services, Manufacturing, and other stakeholders to resolve supplier quality issues. • Identify, document, and close gaps between Supplier Quality practices and corporate and local procedures, ensuring regulatory and procedural compliance. • Guide and mentor peers in the application of statistically based quality engineering methodologies, including data analysis, interpretation of results, and risk-based decision making. • Assess existing supplier quality processes and recommend improvements to enhance compliance, efficiency, and robustness. • Support supplier qualification, performance monitoring, and ongoing quality development activities, including on-site and remote engagements. • Participate in supplier audits, quality reviews, and business reviews as required. • Ensure supplier quality activities comply with cGMP, global pharmacopoeias, and international regulatory expectations. • Prepare and maintain clear, concise, and compliant documentation, metrics, and reports for internal and external stakeholders.