Senior Manager QA Software Compliance | Senior Manager QA Software Compliance (f/m/d)

Job Summary

This role seeks an experienced and motivated professional to join a software quality assurance team, focusing on ensuring compliance with critical regulations like IVDR, FDA 21 CFR Part 820, and cybersecurity requirements for medical device software. The successful candidate will collaborate with development teams, review and approve software documentation in international project teams, and uphold Design Controls and regulatory standards. They will also be responsible for identifying deviations, supporting corrective actions, driving continuous process improvement, and conducting internal software audits, while also contributing to audits and inspections by regulatory authorities. This position offers a chance to play a pivotal role in maintaining high-quality and compliant medical device software.