Quality Assurance business leader and people manager with over 20 years of repeatable success in leading high performance and well- structured functional quality teams with the organizational objective to achieve customer satisfaction.
Solutions driven leader with a proven track record of building internal and external relationships, overcoming challenges to improve products/services and identify opportunities for innovation which support strategic objectives.
Experience in regulated environments including: Manufacturing, Medical Device, Blood & Tissue and Non-Profit settings. ISO 9001, 13485, 22301, FSC22000, 21CFR 111, 820, 211
Specialties include: Quality Management System implementation, management representative, industry and regulatory/compliance inspection host, FDA and other regulatory communication, management review and business continuity planning, cross-functional leadership, budget development, operational objectives and KPI planning and reporting, audit program management, failure analysis and problem solving solutions to quality and compliance issues including those that involve recalls.