Qualification and Validation Specialist | Mitarbeiter Qualifizierung/Validierung (m/w/d)

Job Summary

This role seeks an engaged logistics and technical specialist to join a growing German medical device manufacturer specializing in Assisted Reproduction Technology (ART). The core responsibility involves ensuring regulatory compliance through comprehensive qualification and validation activities. Day-to-day tasks include qualifying critical equipment (IQ/OQ/PQ), drafting and reviewing validation plans and reports for processes, methods, and software, and creating Standard Operating Procedures (SOPs). The specialist will also be crucial in quality assurance (QA), handling non-conformities, complaints, CAPA, conducting data analysis, and participating in internal and external audits. The ideal candidate holds a Master of Science in Biology, Biotechnology, or a related field, coupled with at least two years of professional experience in regulated environments (ISO 13485). This position offers close collaboration with highly qualified colleagues, a culture that values initiative, and opportunities for continuous professional development.