Quality Officer

About MedendoThe healthcare sector is facing an imminent productivity gap due to an ageing population, cost pressure and high administrative burden. Medendo’s mission is to make healthcare affordable and accessible to all by supporting and unburdening healthcare workers in all their daily tasks.Our product is an AI Scribe that provides a speech-to-text reporting service. Our results so far are amazing but far from enough. To truly help healthcare employees, we need to provide our customers with a unified AI-powered experience for all their daily proceedings. This is our workspace.Medendo is a tight-knit team on a mission with a relentless focus on providing value for healthcare professionals. Because we’re looking for reinforcements, this is a unique opportunity to be one of our early hires.Role OverviewAs Medendo’s Quality Officer, you’ll be responsible for everything that enables us to deliver qualitative, safe, and compliant products.At Medendo things move fast, it’s your responsibility to help us do this within the boundaries of the important legal frameworks, without impeding the speed too much. This requires you to think and work beyond the scope of a traditional compliance role. Working closely with product, engineering, and operations to make quality and security part of our everyday workflow. You’ll also work directly with healthcare professionals to validate and verify our clinical models and workflows, ensuring they are safe, effective, and suitable for real-world medical use.When faced with challenges, you can think and act holistically balancing risk, regulation, and practical implementation.Examples of this include:Problemsolve with the team, providing multiple legal angles on which we can build our solutions;Collaborating with developers to embed traceability, validation, and documentation requirements into our release process;Preparing for and coordinating internal and external audits, ensuring Medendo remains on top of it’s game;Translating complex standards en guidelines into clear, actionable processes that help the team move fast and safely.Key Responsibilities🧩 Quality & Security Systems - Maintain and improve Medendo’s ISMS (NEN 7510 / ISO 27001) and build our QMS to prepare us for MDR approval.⚙️ Product Development Integration - Make sure that quality, validation, and traceability requirements become a part of development and release processes.🩺 Clinical Validation - Collaborate with healthcare professionals to validate and verify our models and workflows, ensuring they are not only safe and suitable for extended functionalities but maintain the great user experience.🕵️ ♀️ Audits & Point of Contact - You are the main point of contact for our external auditors and the notified body. You will lead internal and external audits, and determine follow-up actions.🌱 Culture of Quality - Quality is ingrained in our culture. You are the cornerstone of this culture. You help the team to translate our processes into day to day habits. You enable everyone to own their piece of the quality and compliance puzzle.Your SkillsQuality & Compliance📋 Understanding of MDR, ISO 27001, NEN 7510 or ISO 13485, the AI-act, and eagerness to learn and expand your expertise.🧠 Able to translate standards and regulations into clear, practical processes.🔍 Comfortable running internal audits, risk assessments and documentation reviews.📄 Organized and detail-minded with strong documentation and reporting habits.Collaboration, Communication & Ownership🤝 Works easily with engineers, product teams and healthcare professionals.🩺 Helps validate Medendo’s models and workflows with real-world clinical partners.🗣️ Explains complex compliance topics clearly to non-specialists.🎯 Balances precision with a practical, get-it-done attitude.OpportunityOpportunity to join an early-stage startup with significant growth potential at the crossroads of AI and Healthcare;Competitive salary (€50.000-€75.000) and equity options in line with your experience;Collaborative and inclusive team culture with a focus on personal and professional growth.How to ApplyIf you’re excited about transforming the healthcare industry with cutting-edge technology and possess the skills to drive technical excellence at Medendo, we’d love to hear from you. Please submit your resume explaining why you’re excited about Medendo and how your background makes you a strong fit for this position to careers@medendo.com.Please make sure you are aware of our your rights, read about how we deal with your data here:📄Privacy Statement for job applicants