Exemplar LINK Profile

Successful quality professional with an extensive background in quality systems implementation and auditing, supplier quality management, root cause analyses, risk management and problem solving with a focus on FDA and globally regulated life sciences operations. Specialties: Quality Systems • Auditing • Supplier Quality Management • Root Cause Analysis • cGMP Compliance • Change Management • Regulatory Experience (Pharmaceutical and Medical Device) • CAPA • Risk Management • ISO Standards (ISO 9001, ISO 13485, ISO 17100, ISO 27001)