8-10 years of experience in medical device software testing, with a strong understanding of regulatory requirements.
Ensure that software testing practices comply with regulatory requirements (FDA 21 CFR Part 820, ISO 13485, IEC 62304) and organizational QMS standards.
Develop and maintain comprehensive QMS documentation.
Proficiency in test automation tools, programming languages, and software testing methodologies.
In-depth knowledge of medical device software development and testing standards.