Qm Assistant

Fraunhofer MEVIS is a globally renowned development center in the international research community for computer assistance in digital medicine. We pursue a patient-centered and clinical workflow-oriented approach to solving clinically relevant challenges in image
- and data-based diagnosis and therapy. To provide real-world solutions in line with regulatory demands to clinical and industrial partner, Fraunhofer MEVIS operates a quality management system according to the EN ISO 13485 (Medical Devices) standard with a special focus on implementing a software development process in compliance with IEC 62304.

**What you will do**

As part of the quality management team you will support the implementation and controlling of medical device related quality and regulatory tasks in research and development projects at Fraunhofer MEVIS. Our mission is to ensure the qualification of development results as medical devices at the interface between cutting-edge research and product ready solutions for clinical use. In particular, you will support the
- writing of technical documentation in projects
- assessment and qualification of process tools and suppliers
- maintenance of process documents and monitoring of implementation implementation of regulatory requirements**What you bring to the table**
- Experience in the area of quality management, preferably in the context of software development
- Bachelor degree or equivalent in computer science, engineering, science or related field.
- Solution-oriented and structured way of working, good communication and interpersonal skills
- Good German and English language skills

A background in regulatory affairs for medical devices (MDR, ISO 13485), quality assurance for medical device software (IEC 62304), or information and data management and protection (GDPR) is a plus.

**What you can expect**

You will be able to drive the organization of quality management at our institute, promote agility work concepts, and develop your career as a quality assurance expert. You will work
- with excellent and highly motivated interdisciplinary teams
- in a modern and innovative environment with flat hierarchies
- in a friendly and appreciative working atmosphere where diversity is valued, and equal opportunities are promoted
- with a wide range of internal and external training and development opportunities
- with a good work-life balance thanks to flexible working hours and the possibility to partly work from home

The position is initially limited to 2 years. However, we are aiming for long-term cooperation.

With its focus on developing key technologies that are vital for the future and enabling the commercial utilization of this work by business and industry, Fraunhofer plays a central role in the innovation process. As a pioneer and catalyst for groundbreaking developments and scientific excellence, Fraunhofer helps shape society now and in the future.

If you have any questions about the position itself, please contact

Stephan Zidowitz

If you have any questions about the administrative procedure, please contact

Stefanie Jassmann

Fraunhofer Institute for Digital Medicine MEVIS

Requisition Number: 70041 Application Deadline: