Quality Manager (F/M/D)
We’re a Hamburg, Germany-based start-up with the mission to democratize cancer diagnostics. We apply cutting-edge artificial intelligence to support pathologists to identify cancer quickly and accurately. Our AI solution is the world’s most widely used AI-based digital pathology tool and the first AI to be used in clinical histopathology routine for primary diagnostics in the USA. We have been voted as one of the top 10 German startups of 2020 by the German Entrepreneurship Price Committee.
We solve one of the most pressing challenges in modern healthcare: Demands for complex medical image analysis are increasing rapidly, but the number of cancer experts remains stagnant. We build support tools for visual diagnosis using state-of-the-art deep learning. Our tools help cancer experts deliver reliable diagnoses and focus on areas where human expertise is indispensable. Optimizing cancer diagnostics with machine learning is challenging and requires the brightest minds. At Mindpeak, you will work closely with a highly experienced team of industry experts in deep learning, pathology and entrepreneurship in an inspiring and motivating environment.
As a Quality Manager, you will develop, implement and control the quality system and standards for our medical software products, which are used in a digitalised and partially automated workflow in pathology. You are the center of competence for quality system and the quality management. With your deep knowledge of medical software development and your experience in start-up environments you will bridge the gap between highest quality standards and the requirements of a dynamic and fast moving high-tech company.
Together with you we make a difference in the world and shape the future of cancer diagnostics!
- Analysis,, optimization and maintenance of our quality management system, compliant with all regulatory requirements for a medical device (ISO 13485,...).
- Adaptation of the QM system to the requirements of a software start-up company
- Development of a certification strategy, responsible for the creation of the required processes and templates
- Maintenance and optimization of a documentation system compliant with all required regulatory requirements in the EU and USA (CE, FDA)
- Ensuring quality and compliance for our SW product portfolio
- Risk identification and management of new and existing products
- Verification and validation according to applicable standards and regulations such as ISO 13485 and US FDA
- Coordination of all quality topics with the project partners involved
- Advising and training staff and management on quality, standards and regulations and supporting their efficient implementation
- Planning and carrying out internal and external audits
- Excellent university degree in the field of medical technology or comparable
- Multi-year professional work experience in test and quality management in agile and classic IT environments, especially with medical software products
- Work experience in a start-up company, preferably with medical SW products
- Knowledge of all relevant standards for the development of medical software
- Knowledge of requirements engineering is an advantage
- Independent, structured way of working to systematically process, prioritize and summarize complex issues
- Excellent written and spoken English and strong communication skills
- Dedicated professional who will go the extra mile to provide support to the team
- Understanding Machine Learning is a plus
- Your path to become an impactful leader into the future of AI-based cancer diagnostics
- The opportunity to make a difference in the world with your work and bring cancer diagnostics to a whole new level
- Exciting varied work in an upscaling company with new challenges everyday
- An open and creative work environment
- Flat hierarchies and quick decisions
- Exchange of knowledge and close cooperation with exceptional colleagues in a highly motivated international team in one of Germany’s leading AI startups
- Central office location with fascinating workspace view over the Hamburg harbor
How to apply
Send your application as Quality Manager (m/f/d) with your salary expectations and earliest possible starting date as email via the link below.