Quality and Process Engineer – Scientific Affairs | Quality & Process Engineer (m/w/d) – Scientific Affairs

Job Summary

This role involves ensuring that medical products meet the highest quality and safety standards by developing and optimizing critical processes within Scientific Affairs. The Quality and Process Engineer will be responsible for defining and managing sterilization, reprocessing, and product packaging processes, significantly contributing to patient safety and regulatory compliance. Key duties include leading risk management activities for the entire product portfolio related to sterilization, creating and maintaining quality documentation (SOPs, work instructions), and actively supporting CAPAs and quality deviations. The position requires a background in engineering or biotechnology, initial professional experience in the medical device or pharmaceutical industry, and strong knowledge of quality management and process validation. This is an attractive opportunity to work interdisciplinarily with R&D, Production, and Regulatory Affairs in the future-oriented medical technology sector, directly impacting patient well-being.