charles montgomery

Developed and implemented Root Cause Analysis processes for a pass/fail testing lab within Product Complaints department for STERRAD® sterilizers. Root Cause Analysis - Completed root cause investigation of 2nd highest replaced capital component - Piloted root cause investigation projects leading to identification of process gaps and implementation of more robust SP’s and WI’s - Built Electro-mechanical and systems understanding of STERRAD® sterilizers (controller interfacing with electrical and mechanical subassemblies) Cost avoidance ~ 700-1000 hours yearly due to creation and implementation of test plans to reduce returned product testing time Trained Product Complaints department to high level functional understanding of STERRAD® sterilizer operation, software controls and associated consumables Increased visibility and awareness of silo’d Complaints Lab group to other groups within organization (MFG, R&D, Service) through one on one relationship building efforts and group presentations Troubleshoot and maintained operation of capital equipment

* Supported in-house manufacturing lines. Responsibilities included product troubleshooting, * dispositioning non-conformances and composing room/equipment validations. * Investigated and dispositioned electro-mechanical and consumables NCRs * Composed IQ/OQ/PQ, executed, and composed reports for installation of Munters desiccant * dryer for humidity and temperature controls of storage room with Kaye® Validating system * Composed IQ/OQ and execute Environmental Health and Safety (EH&S) assessment for * welder involving Lockout Tag-Out, Ergonomic Assessment, Zero Access Safeguarding * Closed > 40 NCRs month of April, 2013 contributing to “green” dept. metrics * First successful NCR to pass 3rd party internal audit

* Supported new product feasibility testing * Supported FDA 510k submission testing

* Equipment maintenance * Milling and assembly * Quality control of parts, dimensional analysis

* Support Product Management (Life-Cycle Management and New Product Implementation) and Technical Service Engineering (Field Service) organizations. * CAPA owner resolving Field-Action process gap * Own Technical Bulletin process; information flow from in-house to Service organization * Product training classes and town hall product updates * Worldwide technical support for capital equipment * Support component obsolescence and integration * Mentor JnJ rotational talents in product management activities * Create and manage teams responsible to drive and host company charity events * Site lead for Supply Chain and PM Credo Teams

Drive multi-million dollar cost savings projects. Technical and strategic lead on “Cost to Serve” initiative; retain revenue from service contracts. Responsible for the development and execution of comprehensive road map for overall Cost to Serve strategy to achieve the ASP Profitability Improvement Plan. Manage team of 8 Field Service Leads (Regional Leads to >100 US Field Engineers) in identifying and executing projects to improve overall field process efficacy and drive cost reduction Manage direct report and off-shore team for Service process and documentation updates Lead organizational Kaizen for scrap loss; opportunity of 1MM Identify and remediate emerging field issues from new product launch and sustaining efforts resulting in reduced customer downtime and product design improvements Delivered 2.5 MM savings recurrent annually (since 2016) through development and implementation of innovative component in-field cleaning processes, creation of spare parts from higher level assemblies and PM and calibrations equipment optimization

Activities and Societies: Biomedical Engineering Society