Description
SUMMARY OF QUALIFICATIONS * Certified Master Black Belt able to lead and influence people at all levels within a Manufacturing organization. * Proficient in the DMAIC Six Sigma and DMAIC/PDCA Lean Roadmaps, including many different lean and statistical methods such as: Value Stream Mapping, 5S, Visual Management, Quick Changeover, Kaizen Events, Problem Solving, Mistake Proofing, Gap Analysis, Standard Work, Process Map, C&E Matrix, FMEA, Multivariate Analysis, Categorical Data, Statistical Process Control, Maintenance, Reliability, Regression, Linear Modeling, Design of Experiments, Sampling, Exploratory Data Analysis, Hypothesis Testing, Process Capability/Performance, Measurement System Analysis/Kappa Testing, among others. * ASQ Certified Quality Engineer with In-depth knowledge and work experience of regulations such as: ISO 13485, CFR Part 820, CFR Part 11, ISO 14971, Canadian Medical Device Regulation (CDMR), Japanese Pharmaceutical Affairs Law (JPAL), European Medical Device Directive (MDD), and Brazil Medical Device Regulations (ANVISA). * Products/Systems/Processes Background: Over 17 years of experience working in Manufacturing. Experience working with Continuous Manufacturing of Plastics by Extrusion, and Plastics Manufacturing by Injection Molding, Design and Manufacturing of Robotic/Non-Robotic Medical Devices. Experience with engineering research and development, quality, supply chain, production, sustaining and improving products during the lifecycle of highly technological and complex medical devices. Experience with systems and product software. Experience with single use, medium to high volume plastic consumable products. * Excellent presentation and public speaking ability in English and Spanish.
Accomplishments
Highlights:
Keywords
