Sr. Quality Assurance Specialist
Current• Reviewed medical equipment notifications ensuring FDA and ISO compliance• Prepared detailed product analysis, trending and metrics for management review• Implemented various process improvements for data bases and data trending, resulting in increased productivity for the QA team• Conducted complaint compliance training with technical support• Created and maintained complaint tracking spreadsheets for QA/RA management• Led weekly cross-functional meeting for review of… Show more • Reviewed medical equipment notifications ensuring FDA and ISO compliance• Prepared detailed product analysis, trending and metrics for management review• Implemented various process improvements for data bases and data trending, resulting in increased productivity for the QA team• Conducted complaint compliance training with technical support• Created and maintained complaint tracking spreadsheets for QA/RA management• Led weekly cross-functional meeting for review of SMDRs and ensured timely resolution per FDA guidelines Show less