Qualification and Validation Specialist (Medical Devices) | Biologe (m/w/d)

Job Summary

This role is for a dedicated specialist supporting Quality Assurance activities, focusing heavily on qualification and validation within a German medical device manufacturer specializing in Assisted Reproductive Technology (ART). Day-to-day responsibilities include qualifying critical equipment (IQ/OQ/PQ), creating and reviewing validation plans and reports for processes, methods, and software, and developing/reviewing Standard Operating Procedures (SOPs). The specialist will also handle feedback, non-conformities, complaints, and CAPA, including data and trend analysis, and participate in internal and external QA audits. Key requirements include a Master of Science degree in Biology, Biotechnology, or a comparable field, and at least two years of professional experience in regulated medical devices (ISO 13485) or similar industries, with a focus on equipment qualification and process validation. The position offers close collaboration with highly qualified colleagues in a growing, multinational environment that values initiative and offers professional development opportunities.