Medical Technology Validation Expert - Hortonville, United States - Horizon Innovations

Horizon Innovations
Horizon Innovations
Verified Company
Hortonville, United States

17 hours ago

Meredith Sinclair

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Meredith Sinclair

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Description

Your tasks

  • Creation and updating of compliant validation and qualification plans as well as documentation
  • Conducting necessary (re-)validations and (re-)qualifications (DQ-IQ-OQ-PQ) of procedures, processes, equipment, and software, as well as initiating measures in case of deviations
  • Creation and review of specifications, risk analyses (FMEAs), design documents, and processes
  • Application of statistical and analytical methods to ensure reliable systems, processes, and products
  • Creation and updating of procedures, testing, and work instructions, including user training
  • Preparation and participation in audits
  • Quality planning for development/customer projects

Your profile

  • Completed engineering degree or technical education with a deep understanding of processes
  • Several years of professional experience as a validation expert in the medical technology/pharmaceutical industry
  • Good knowledge of statistical and analytical methods, as well as the application of relevant standards and regulations
  • Solution-oriented and pragmatic approach, hands-on mentality, and good teamwork and communication skills
  • Proficient in MS Office
  • German level at least C1 and English level at least B2 in spoken and written form

Our benefits

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