Quality Manager for IVDR Software (m/w/d)

The inno-train Diagnostik GmbH is a producer of medical diagnostics with around 50 employees and headquarters in Kronberg im Taunus, near the Main metropolis Frankfurt, as well as a sales office in the USA. We are an internationally operating provider of transfusion medicine diagnostics with a focus on molecular biological analyses in the fields of HLA, blood groups, and human genetics, as well as laboratory automation. Take a look at our homepage.

As a producer of in-vitro diagnostics, inno-train is DIN EN ISO 13485 certified and our products are subject to the European IVDD Directive 98/79/EG or the European IVDR Regulation 2017/746. Due to the worldwide distribution of our products as in vitro diagnostic devices, we are also required to fulfill regulatory requirements outside Europe and obtain approvals, for example, based on American FDA guidelines.

Tasks

Creation and maintenance of Technical Files for IVDR, particularly for our software products, interface/point of contact for software development regarding regulatory requirements, organization, participation, and conduct of internal, external (TÜV) and supplier audits, product registrations abroad, fulfillment of the requirements imposed by ISO and IVDR on inno-train.

Qualification

• Completed studies or vocational training in computer science, medical informatics, software engineering, technical computer science, or a comparable qualification.
• Multiple years of professional experience in quality management or the development of regulated software, ideally in the context of medical devices or IVD.
• Good knowledge of relevant standards and regulations, particularly ISO 13485, IEC 62304, ISO 14971, IVDR.
• Understanding of software development processes, risk management, traceability, and handling of SOUP/Open-Source components.
• Experience with audits, CAPA processes, and technical documentation is advantageous
• Structured, self-reliant working style, as well as very good German and English language skills in writing and speaking.

Benefits

• A full-time employment with an unlimited employment contract.
• Attractive conditions, e.g. 30 days of vacation.
• Flexible working hours.
• You will work in a team of 4 people.
• Exciting challenges in a versatile task area.
• Individual support for your talents, opportunities for further development.
• Variety and demanding tasks in a growing company.
• A pleasant working atmosphere in a dynamic and motivated team.

We look forward to your application!

If interested, please send us your application with your earliest possible start date and salary expectations to Sabine Scholz. For inquiries, I am available by phone: +49 6173 607930

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