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