Mitarbeiter im Qualitätsmanagement (m/w/d) für Software als Medizinprodukt/IVD

Permanent Employee, full-time, Reutlingen

Your mission

• As a member of the quality management team, you will be the interface between the development and marketing of software products in the field of diagnostics of infection-associated diseases
• You keep the existing QM system in the field of algorithm-based molecular diagnostics up to date and implement it independently and efficiently in reality
• You support the registration of new medical devices/IVDs and the regulatory launch of our products in EU countries & the UK
• You provide our customers with information on regulatory issues
• You continuously improve our QM system and adapt it to emerging requirements
• You contribute your own ideas for the implementation of QM guidelines in the development of software-based infection diagnostics
• You collaborate in the establishment of the QM system in the medical laboratory
• You work with us at our location in Duisburg or Tübingen-Reutlingen or proportionally in the home office
• You perform internal and external (laboratory) audits, which requires an occasional willingness to travel

Your profile

• You have a university degree in a relevant subject (e.g. life sciences/computer science) or several years of professional experience
• You think analytically and are a strong communicator
• You have already established QM systems, developed them further and/or accompanied them through an audit
• You know the standards and laws (EU & UK) for active medical devices/IVD, especially for stand-alone software as medical device/IVD, and you enjoy applying and further developing this knowledge
• You have experience in cloud computing and the resulting legal requirements
• You are fluent in German and English, both written and spoken
• If applicable, you have professionally developed medical devices and/or software yourself
• You take responsibility for your own results and thus for the success of our customers and of Noscendo
• You are motivated, ambitious and share our claim for highest quality
• You are confident in using G-Suite or similar products

What awaits you

• A position in a fast-growing start-up that is expanding internationally
• The opportunity to put your own ideas into practice
• A dynamic, diverse, high-performing team that values your efforts
• 30 days vacation
• Flat hierarchies and short communication channels
• High-quality technical equipment
• Internal company pension scheme
• Numerous other benefits