What can you expect? You take care of the quality management system (QMS) and ensure compliance with all relevant laws, guidelines, and standards You implement and maintain QM standards, processes, and new regulatory requirements, particularly in accordance with ISO 13485 and IEC 62304 You review and create regulatory process instructions (SOPs) and communicate with authorities You support the preparation of documents for the market authorisation of our Class I software medical devices, including compliance with standards You coordinate corrective and preventive actions (CAPA) and are responsible for risk management and change control What do we offer? You will be part of a team that creates innovative solutions for oncological patients in the German healthcare system We offer flat hierarchies that allow a high degree of independence and freedom to develop your creativity and contribute your own ideas We are a dynamic and diverse team and value positive, direct and open interaction with each other We offer flexible working hours We are an Equal Opportunity Employer What should you bring along? You have a degree in quality management, engineering, medical technology, or a comparable qualification You possess sound knowledge of ISO 13485, IEC 62304 standards, and regulatory requirements for medical devices You have experience in risk management, CAPA processes, and quality audits You demonstrate strong communication skills and experience in liaising with authorities and implementing regulatory requirements You are able to train employees in quality topics and continuously improve the QM system You are fluent in written and spoken German and English, and it is nice to have experience with breast cancer