A tactical and results oriented Quality Systems professional with proven success in creating and deploying quality system under fast-track conditions and achieving ISO/EN certification on first pass. Experience in: forming departments and deploying compliant quality systems for a broad range of medical devices. Manage third party audits by FDA, European, and Corporate auditing bodies. Skilled in all aspects of total quality management, continuous improvement, customer focused initiatives, fostering teamwork, and leadership. Specialties Planning and implementing quality systems strategy, Compliance within the life sciences space: ISO 13485, ISO 9000, GxP CFR parts 11, 50, 210, 211, 820, ICH Guidelines… Process mapping, deploying quality systems, and certification. Design control and transfer, CAPA, Document Control, Complaints, Management review (resource, process, data and information management), metric reporting… Performing Quality Systems due-diligence on Merger & Acquisition projects. Leadership and team building.read more ...read less ...
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