Quality Assurance
20 hours ago
Vitoria-Gasteiz
At vitalera, we're transforming the way we care by deploying a remote AI solution across 60+ hospitals in more than 5 countries, processing over 1 million clinical events, providing AI-driven remote care, and smart connecting with 500+ medical devices and wearables through interoperable FHIR/HL7 APIs and direct EMR/EHR integration. Our solution augments healthcare capabilities and supports remote care across cardiology, oncology, respiratory disease, diabetes, behavioral health, weight management, and elderly care. We hold CE Mark, ISO 27001, ENS Alto, and are fully HIPAA and GDPR compliant. We are bootstrapped, profitable, and fast-growing — backed by clinical advisors, including Dr. Josep Brugada, MD, PhD, and by partnerships with leading healthcare institutions across Europe. If you want to see our impact, visit: www.vitalera.io Context: We're growing rapidly. At the same time, we're scaling internationally, evolving our remote care solution and AI Health Agent capabilities, and adding new clinical pathways and partnerships every quarter. To do this safely — and at the level our patients, clinicians, and partners deserve — we need someone who can take full ownership of quality across our software platform. Not someone who treats QA as paperwork, but someone who sees it as the backbone that makes everything else possible. If you're energized by the idea of building a quality system that genuinely protects patients (and isn't just there to pass audits), this might be your place 🚀 What You'll Do: Your mission will be to own and elevate the quality function across Vitalera, ensuring our platform meets the highest standards of safety, reliability, and regulatory compliance — while supporting the team's ability to move fast. You'll sit at the intersection of regulatory affairs, engineering, product, and clinical, leading our QMS, driving audit readiness, and embedding quality into how we build software. What to expect during your first months with us: Month 1: You'll focus on shadowing key team members and getting up to speed with our platform, QMS, clinical use cases, and compliance landscape. You'll familiarize yourself with our current technical documentation and quality processes, and you will start testing everything. By the end of month 3: You'll be contributing independently — owning the QMS day-to-day, driving Q&A resolution, supporting audit readiness, and beginning to identify structural improvements to our quality processes. After 6 months: You'll be fully established as the quality at vitalera. You'll be proactively shaping our quality strategy, preparing the organization for international scale, and mentoring the broader team in a culture where quality is everyone's responsibility. Responsibilities: • Plan, execute, and document quality controls across product releases, ensuring every version meets defined acceptance criteria before reaching clinical environments, • Perform systematic functional, regression, and integration testing across our platform, mobile apps, and APIs, • Validate end-to-end clinical workflows, ensuring data integrity from medical devices and wearables through to EMR/EHR systems, • Lead and continuously improve Vitalera's Quality Management System (QMS) aligned with ISO 13485, IEC 62304 and MDR (EU 2017/745), • Oversee verification & validation activities across the software development lifecycle, • Define, monitor, and report quality KPIs (defect density, escape rate, test coverage) to drive continuous improvement, • Collaborate closely with the R&D team on design controls, risk management, and technical documentation., • Embed a culture of quality across engineering, product, and clinical teams. 🩺 With whom will you work : You'll work closely with our CTO, our R&D, clinical, and regulatory teams, and collaborate directly with the CEO on strategic quality decisions. 💻 Requirements • 5+ years in Quality Assurance / Quality Management within medical devices, SaMD, or healthcare technology, • Proven track record executing hands-on quality controls and testing on software products (functional, regression, integration), • Familiarity with cybersecurity standards is a strong plus, • Strong cross-functional leadership — comfortable working with engineers, clinicians and regulatory teams, • Excellent problem-solving skills and ability to translate complex regulatory requirements into practical processes, • Bachelor's degree in Engineering, Life Sciences, Quality Management, or related field, • Professional English (working language is Spanish); Spanish is desirable, • Available to work on-site in our Gipuzkoa office (Elgoibar area) What we offer • 💰 Competitive salary based on experience, with flexibility for freelance arrangements, • 🌍 On-site role with flexibility for occasional hybrid sessions when work allows, • 🕓 Flexible working hours, • 💻 Laptop and equipment of your choice, • 🩺 An impact-based role in a profitable, bootstrapped healthtech company where your work directly impacts patient safety., • 🤝 Direct collaboration with founders, clinical advisors, and a tight-knit team — no bureaucracy, fast decisions., • 🏔️ High quality of life in the Basque Country — close to nature, world-class food, and a strong industrial and tech ecosystem.
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