Quality Manager AI-Enabled medical device (mfd)

About Us

At AURA Health Technologies GmbH we develop AI-powered ultrasound software that makes breast cancer surgery safer more precise and more efficient. Our technology brings cutting-edge image processing and artificial intelligence directly into the operating roomwith the goal of improving the lives of over 500000 patients every year.

From our headquarters in Berlin an interdisciplinary team of medical professionals engineers and entrepreneurs is working to transform surgical standards collaboration with leading clinics and research institutions we are clinically validating our solution and preparing for international scale-upstarting in the USA and stands for clarity. For health. And for the fusion of medical excellence with technological intelligence.

Why Were Looking for You

As a QM Manager at AURA Health Technologies GmbH you wont just be maintaining complianceyoull be shaping the quality backbone of next-generation imaging technology. Embedded in our R&D-driven environment youll work at the intersection of innovation and regulation helping build AI-based medical devices that meet the highest standards of safety and performance.

This role is not about oversightits about ownership. Youll lead quality activities establish and evolve our QMS and collaborate closely with R&D clinical and regulatory teams. Youll be instrumental in preparing for our first audit and laying the foundation for scalable compliant product 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 Europes most dynamic MedTech startups. If youre entrepreneurial passionate about AI in healthcare and eager to build systems that matterthis is your opportunity.

Tasks

• 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.
• Work on continuous improvement initiatives.

Requirements

• 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.
• Entrepreneurial mindset with the ability to work independently and proactively in a fast-paced evolving environment.
• 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.
• Readyness to grow into a senior QM role QMB or PRRC.

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
• Respectful and inclusive work culture
• Opportunity to improve breast cancer care

Success Measures

Within 3 Months:

• You have reviewed and understood AURAs existing QMS including all relevant SOPs templates and workflows.
• A comprehensive gap analysis is conducted comparing the current QMS against audit requirements
• Gaps are being closed.
• You are actively collaborating with the team.

Within 6 Months:

• AURA successfully comleted its first ISO13485 certification audit.
• Any non-conformities or observations from the audit are addressed promptly with corrective actions implemented and documented.
• The preparations for the MDR audit are initiated.
• Core QMS processes are running smoothly across the whole teams with quality procedures actively used and continuously improved.

Application Instructions

You dont meet every single requirement No problemif youre motivated to take responsibility and grow with us we encourage you to apply anyway.

We are committed to building a diverse team that thrives on different perspectives. Thats why we especially welcome applications from individuals with underrepresented backgrounds and experiencesregardless of gender origin religion age disability or sexual identity.

If you have specific needs during the application process just let us knowwell find a solution.