Exemplar LINK Profile

Quality focused leader with 20+ years of experience making technical & highly regulated content accessible to global audiences. Skilled in setting strategic vision and managing all stages of project lifecycles, with a strong focus on ISO standards compliance (ISO 9001, ISO 17100, ISO 18841, ISO 21998). Creates a positive user experience regardless of native language for IVDD and eLearning products. Specialties: Quality Systems • Auditing • Supplier Quality Management • Root Cause Analysis • CAPA • Change Management • Process Optimization • Regulatory Experience (Medical Device) • Risk Management • Strategic Planning • Localization • Translation Management • ISO Standards (ISO 9001, ISO 13485, ISO 17100, ISO 18841, ISO 21998)