Ray Klein Email & Phone Number

Process/product development and quality professional leading engineering teams and cross-functional teams on projects from concept to production and through the product life cycle. Solid understanding of development phases using structured methods to insure that critical/long lead items are resolved and costs are minimized. Uses refined practical skills balanced with theoretical skills to ensure product quality, effective process flows and create robust designs. Team player who promotes cross-functional involvement to assure clean product launches.CORE SKILLS• Leadership and Mentoring• Process Flow & Improvements• Problem Solving (Six Sigma Black Belt) • Validations (Plans, IQ/OQ/PQ)• NCRs and CAPA • Quality Methods (SPC, Control Plans)• Project Management • Cleanroom Certification (ISO 11137)• Sterilization (Gamma & E-Beam) • Seven published patents• Cellular manufacturing and DFM • Geometric Dimensioning & Tolerancing• Regulatory Compliance - 21 CFR Part 1271, Part 820, ISO 13485

Listed skills include Iso 13485, Medical Devices, Quality System, Engineering, and 16 others.