3 days ago

Senior Engineer Quality Management IT (f/m)


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Senior Engineer Quality Management IT (f/m)

As one of the world's leading manufacturers of cardio- and endovascular medical devices, BIOTRONIK is headquartered

in Berlin, Germany, and represented in over 100 countries. The work of our committed, highly specialized, exceptionally

skilled employees results in crucial advancements in the world of cardiology and changes the lives of patients every day.

Please join us as :

Senior Engineer Quality Management IT (f/m)

The Quality Management department ensures compliance to the international standards and regulations for the manufacturing and distribution of medical devices and combination products. A diversified team of specialists supports the complete organization in the implementation of adequate processes and activities, as well as organizing and managing external audits.

Your Responsibilities
  Your Profile
  • Managing the implementation of quality relevant business processes into computer systems together with ICT Managers and business stakeholders
  • Single Point of Contact (SPOC), representing entire Quality Assurance / Regulatory Affairs (QA/RA) within the defined IT projects
  • Reviewing and approving computer system documentation, such as risk analysis, user requirement specifications, validation & verification reports, traceability reports, change requests
  • Training and educating the organization for the IT system validation processes
  • Project Management for cross-functional projects including the implementation of IT tools
  • Maintaining the IT validation master plan
  • University degree relevant to the position or an equivalent mix of education and experience
  • Computerized System Validation (CSV) in regulated industry is an asset for this role
  • Successful experience in fields relevant to the position within a life sciences environment or similar industry
  • Experience may include business analysis and business process modeling, designing and implementing quality management systems into the IT environment, IT change management
  • Key user know-how in IT systems (preferably in SAP)
  • Experience of key regulations and methods (21 CFR Part 11, 21 CFR 820, GAMP 5) is an advantage
  • German and English (Level C) verbal and written mandatory

Are you interested in learning more? Then please apply online! We look forward to welcoming you.



Working hours: Full-time  

Type of contract: Unlimited

Job ID: 16781

Contact: Amir Reshef                 


We do not accept applications from Headhunters.