PROJECTS
QMS Implementation
Develop and implement a Quality Management System (QMS) compliant with ISO 13485, EU MDR 2017/745, and other applicable international standards / regulations for a $3M Nuclear Medical Device manufacturer. Timing to implement reduced by 44% using a streamlined implementation approach that allowed for required record creation and 3-4 month data collection history in parallel with governing document creation.
Consulting & Training
Provide independent contractor support to a $20M dollar international consulting and training organization interfacing with its clients to provide consulting services that enhance their Business & Process Management Systems. This includes conducting independent organization site surveillance/certification audits and gap analysis for clients within various business sectors such as Medical Device, Automotive, Aerospace, etc.
Project Management
Provided executive level project management for a $60B pharmaceutical company's merger and acquisition (M&A) vertical integration project while supporting a reorganization of their Medical Device Technology division. Orchestrated full integration and discontinuation of the acquired entities five (5) different Quality Systems governing operations within 100+ countries.
Internal / External Auditing
Providing independent internal auditing / external audit activities for various small to large sized organizations aiding in continued compliance to various Quality Management System certifications. Provide internal audit management, conduct full scale supplier sourcing audits, and 1 to 3 day supplier scheduled compliance audits.