At AURA Health Technologies GmbH, we develop AI-powered ultrasound software that makes breast cancer surgery safer, more precise, and more efficient. From our headquarters in Berlin, an interdisciplinary team of medical professionals, engineers, and entrepreneurs is working to transform surgical standards worldwide. In collaboration with leading clinics and research institutions, we are clinically validating our solution and preparing for international scale-up—starting in the USA and Europe.And for the fusion of medical excellence with technological intelligence.
&##As a QM Manager at AURA Health Technologies GmbH, you won’t just be maintaining compliance—you’ll be shaping the quality backbone of next-generation imaging technology. Embedded in our R&D-driven environment, you’ll work at the intersection of innovation and regulation, helping build AI-based medical devices that meet the highest standards of safety and performance.
This position is ideal for someone who sees quality as a strategic enabler, thrives in ambiguity, and is ready to grow into a leadership role in one of Europe’s most dynamic MedTech startups. Lead the implementation and maintenance of the QMS in compliance with MDR and ISO13485, with a focus on software and AI-based medical devices.
Support the senior Quality Manager and the team in getting ready for the first certification audit and keep AURA ready for follow-up audits.
Collaborate with cross-functional teams (engineering, clinical, regulatory) to embed quality into software development processes.
Drive design control activities across the product lifecycle, ensuring traceability, risk management, and documentation integrity.
Define and maintain quality procedures for software development, including validation, verification, and release management.
Degree in Biomedical Engineering, Software Engineering, Life Sciences, or a related technical field.
Minimum 3 years of experience in quality management for medical devices, ideally with exposure to software as a medical device or in a medical device or AI-based technologies.
Interest in AI-based medical technologies and willingness to grow in a pioneering field.
Excellent communication and documentation skills in English; German is a plus.
Benefits
Unlimited contract with competitive fixed salary
Flexible hours and hybrid work model (minimum 20% in-office)
Structured onboarding and Scrum-based project management
Flat hierarchies and fast decision-making