You're the right fit if: You have a minimum of 5+ years' experience in FDA/ISO 13485 medical device quality operations/manufacturing environments, with a focus on QMS compliance, documenting QMS changes, gap assessments, Audits, Document Control, Training, CAPA's, etc. You're experienced in Data analysis, understanding QMS metrics/key performance indicators (KPI), preparing detailed reports that highlight trends, deviations, areas for improvement, and presenting findings to senior management.