Summary/Description This is a Subject Matter Expert role in Risk Management within the Design Quality Assurance team. The role involves performing gap assessments, planning, organizing, executing, and reporting all usability and risk management activities through collaboration with cross functional teams.…
Key Responsibilities Review and assess the accuracy, completeness, and compliance of all complaint records (including parent and child records) in accordance with internal procedures and regulatory requirements (e.g., FDA 21 CFR Part 820, ISO 13485, MDR). Provide clear, actionable quality…