Validation Expert / Specialist

As a manufacturer in the field of ophthalmology, We supply companies and direct customers worldwide with a wide range of high-quality eye implants for various indications at its Stuttgart location. With our focus on quality, reliability and customer satisfaction, we make a contribution to optimal patient care.



YOUR TASKS WITH US:

• Update and document compliant qualification and validation plans and reports
• Implementation and documentation of necessary (re-)validations and (re-)qualifications of
• cleanrooms (ISO class 7/8), procedures, processes, systems, equipment and, if applicable, software
• Planning, support and accompanying implementation of DQ-IQ-OQ-PQ for processes and
• production facilities as well as initiation of measures in the event of deviations
• Creation and review of specifications, risk analyses, design documents and processes
• Application of statistical methods for ensuring processes
• Regulatory support of teams and projects
• Participation in audits
• Creation, updating and training of procedure, testing and work instructions
• Maintenance and archiving of documents

WHAT YOU BRING TO THE TABLE:

• Completed engineering studies or technical training with a deeper understanding of processes
• Ideally, at least 3 years of professional experience as a validation expert* in medical technology
• Good knowledge of statistical and analytical methods
• Good knowledge of the application of relevant standards and regulations
• Solution-oriented and pragmatic way of working
• Hands-on mentality, ability to work in a team and strong communication skills
• Confident handling of MS Office applications
• Good knowledge of German and English, both written and spoken
  
  

OUR OFFER:

• Varied and challenging task in a future-oriented industry
• Collaboration in a successful company with short communication channels and flat hierarchies
• Freedom for ideas and further development
• Benefits such as company pension scheme, travel allowance, free coffee, etc.
• Good public transport connections