Sold new business projects and “Hands-On” helped medical device/pharmaceutical clients in USA, Puerto Rico, Mexico, England, China, India and Japan for 20+ years to promptly/cost-effectively remediate various adulterated claim, misbranding FDA violations. On-the-job trained (OJT) and helped companies continuously improve/grow/manage their existing business through new product launches using practical, Product Development, Regulatory Approval Path, Risk Mitigation and Lean Six Sigma (LSS) business transformation strategies

• Quality, QMS, Quality System Excellence, Audits, Risk Management, Regulatory Affairs/Compliance/Remediation, New Product Development and Business Excellence Expert with Simultaneous Micro/Macro Vision/ Strategy Development/ Implementation Leadership/ Expertise Over a Product’s Entire Commercialization Cycle of Complex Medical Device/Pharmaceutical Projects in a Matrix Environment with Demanding Deliverables/Timelines and - at times - Supported by a United Nations Project Team

• Company-wide Regulatory Approval Path, Risk Mitigation and LSS Strategies’ Development, Process Mapping/Modeling, New Product/Process Development (NPD, SDLC), Lean Six Sigma (LSS) Product/Process Configuration Redesign / Verification / Validation / Improvement, Commercialization, Management / Remediation

• New Business Salesman, Troubleshooter, Leader, Coach, Mentor, Trainer, Strategy Developer/Implementer/Manager, Doer, Business Transformation Agent and Remediator of Quality Systems (QMS), QSR, cGXP Regulatory Affairs/Compliance and Lean Six Sigma (LSS) Projects

• Innate ability to teach people how to solve/manage technical and business challenges that others had considered unsolvable through OJT, making the complex simple, process mapping/modeling, applying root cause analyses and statistical tools and, securing people's support by effective communication: Root Cause Analysis (RCA), Failure Mode and Effect Analysis (FMEA), Risk Analysis; Experimental Design, Statistics, Modeling

• APIs, Drugs, Aseptic Filling, Injectables, Tribology, Colloids, Creams, Ointments, Tissue/Hemostat/Wound Management, Powders, Gels, Fluidics, Lyophilization, Blood, Tissue, Biomaterials, Biocompatibility, Surface Plasma/Corona/Chemical/Electro-chemical Treatment/ Modifications, Lubricious and Adhesive (Non-lubricious) Coatings and Surfaces, Form/Fill/Seal Packaging, Ultrasonic Welding, Cleaning, Cutting Tools (Blades, Sutures, Needles), Material Degradation Under Normal and Accelerated Aging/ Stress Conditions, Membranes, Filtration, Molding, Extrusion, Grinding, Milling, Electro-etching, Polishing, Passivating, Annealing, Tempering, High Speed/Volume Automated Feeding/ Loading/ Pick-n-Place/ Filling/ Capping/ Labeling/ Packaging/ Assembly Manufacturing Equipment, Ovens, Stability Chambers, Laboratory Systems