Lead Senior Consultant
CurrentExpertise in strategic applications of technologies, including design transfer, design control, project management, risk management, and manufacturing transfers.Extensive experience with quality systems policies, procedures and remediation, with emphasis on the central connections through the CAPA system. Expert facilitator for technical investigations problem-solving teams.Recent consulting engagements have included the following work for clients:- Technical Lead for medical device firm's multi-product, multi-site improvement initiative.- Development, deployment and training for CAPA system structured investigation process, including templates and guidelines.- Facilitation of problem-solving teams.- Independent review of technical/marketing programs.- Technical due diligence for business development assessments. - Technology / product roadmap assessment and development.- CAPA systems and investigation records remediation.- Design transfer process development and program management. - Project and program risk management.