Description
The Software Quality Assurance Representative supports software validation, remediation, change control, qualification, risk management, NCEP, CAPA, and compliance activities across medical device software projects. The role partners with cross-functional stakeholders, reviews qualification deliverables, and manages quality issues in regulated environments. It requires a bachelor’s degree in engineering or a related technical field, 3–4 years of quality, QA, or medical device experience, and knowledge of medical device quality systems, regulations, and computerized system validation.

