Then come and join our global team as Quality Consultant Unique Device Identification (UDI) & Digital Quality (f/m/d).

Choose the best place for your work – Within the scope of this position, it is possible, in consultation with your manager, to work mobile (within Germany) up to an average volume of 60% of the respective working hours.

Even more flexibility? Mobile working from abroad is possible for up to 30 days a year under certain conditions and in selected countries.

Your tasks and responsibilities:

• You actively contribute to company-wide initiatives to ensure UDI compliance and regulatory conformity of software- and non-product-software (NPSW)–related processes within the Siemens Healthineers quality management system, applying appropriate methods such as structured analyses, data-driven evaluations, and process improvement approaches.
• You support the further development of concepts, standards, and applications in UDI data management as well as software- and NPSW-related quality requirements, and you support Siemens Healthineers entities such as Business Areas, Business Lines, functions, and countries in implementing applicable international regulatory and internal requirements.
• You contribute to the creation, harmonization, and continuous optimization of processes, guidelines, and quality requirements related to UDI, software, and data-driven quality aspects.
• You actively shape the development, preparation, and transfer of best practices, lessons learned, and structured knowledge management in the context of UDI, software lifecycle topics, and data-driven quality processes.
• You support inspections, compliance audits, and quality assessments with a focus on UDI requirements, software and NPSW processes, and related data flows.
  
  

To find out more about the specific business, have a look at https://www.siemens-healthineers.com/products-services.

Your qualifications and experience:

• You have successfully completed a master’s degree in a scientific, engineering, or comparable field, such as medicine, pharmacy, medical engineering, or biomedical engineering.
• You bring initial professional experience in quality management for medical devices, particularly related to quality management systems and relevant standards and regulations (e.g., ISO 13485).
• You are also welcome to apply with a bachelor’s degree combined with several years of relevant professional experience in this field.
• You ideally have solid knowledge of implementing international regulatory requirements in UDI and software, such as EU MDR/IVDR, FDA UDI, or SaMD/software-related requirements, or you are willing to acquire this knowledge in a targeted manner.
• You have very good knowledge and practical experience in improvement and change processes, especially in the context of digitalization, data management, and IT-related quality processes, and you are able to analyze complex topics in a structured way and communicate them effectively to different audiences.

Your attributes and skills:

• You demonstrate a strong future-oriented mindset and enthusiasm for topics such as digital health and digitalization.
• You are willing to travel as part of global improvement projects and audits (approximately 30%).
• You stand out through a highly independent working style and a collaborative approach when working across interfaces with Siemens Healthineers entities.
• You complete your profile with very good communication and presentation skills in English and experience in collaborating with international colleagues; German language skills are an advantage.