Implement the Vantive Global Quality Management System 9QMS) and manage local QMS documents including procedures for Quality, R&D, Regulatory, Facilities, etc. for multiple Vantive Twin Cities sites responsibility for results in terms of compliance and product quality. · Knowledge of the global Regulatory and Quality requirements for the manufacture and marketing of medical devices; knowledge of ISO 13485, FDA 21 CFR Part 7, 11, 803, 806, 810, 820, ISO 14971, MDD 93/42/EEC and EU MDR 2017/745.