I am a world-class expert in Supplier Quality Engineering, Design For Manufacturability (DFM), and Six Sigma problem solving methodology, with many years of successful experience in medical devices, aerospace, and high-tech industrial products. I have a proven track record of working directly with R&D to launch innovative new products on extremely aggressive schedules, while outsourcing the manufacturing to international suppliers. Specialties include process improvement, computer system validations, and the implementation of new processes and procedures using best practices and world-class database systems (Oracle, SAP). Responsible for technical writing, editing, review and approval of documents within formal Document Control system workflow (Oracle Agile database) in compliance with FDA Regulations. Highly developed skills include manufacturing and process engineering, Quality System auditing per ISO 13485, DMAIC problem solving, root cause analysis, corrective and preventive action (CAPA), risk analysis and mitigation using Design Failure Mode Effects Analysis (DFMEA), product quality improvement, and cross-functional teamwork and team leadership.Advanced knowledge of the manufacturing technologies for the following: electronics, printed circuit board assemblies (PCBA), motors, electromechanical sensors and systems, plastic injection molding, rubber compression molding, precision machined parts, functional testing and test equipment, Gage Repeatability & Reproducibility (Gage R&R), Quality Control inspections, Statistical Process Control (SPC), Process Failure Mode And Effects Analysis (PFMEA), process validation, box build of final products and subassemblies.
Listed skills include Medical Devices, Fda, Six Sigma Black Belt, Process Validation, and 22 others.