Orpha James

Background

About Orpha James

Over twenty five years of work experience in Medical Device, Contract Manufacturing and Quality Engineering. Design Controls, Designed plastics formulations for Thermoplastics Elastomers and PVC for extrusion profiles. An expert in Medical V&V work while using an analytical approach to problem solving. Project Management, CAPA, Risk Assessment, Sterilization, Post market Surveillance, Supplier Management, Root Cause Analysis using quality tools 8D, 5 Whys, Bio Compatibility, Cost Savings and efficiency in the Plastics fabrication, Electronics, Metal industries. Design Controls, Gap Analysis, Auditing. Lead Quality Systems Auditor for Medical Device focusing on external and internal auditing in accordance with regulatory requirements and standards of MDSAP (QSR 21 CFR Part 820, ISO 13485:2016, CMDR, MDD, JPAL, TGA, and ANVISA). EUMDR 2017/745. Consulting: Contract auditing, Certification Assistance, Documentation preparation, Training. Supplier Certification Audits (Domestic and International) Technical Specialties: Third Party audit, Remote Auditing, Supplier Audits, Risk Management, Design Controls, MDSAP, CE Marking, Canadian Medical Device Applications, Post-Marketing Activities, Supplier Quality, CAPA, Sterilization Validation, Lean Manufacturing, Thermoplastic Elastomer formulation, Extrusion, Engineering, and Strategy. GAP Analysis. TECHNICAL ACCOMPLISHMENTS: • Designed a new technique to test the BI in sterilization process. • Developed Water Clear Elastomer for sippy cups • Mold flow Analysis: Optimized molding conditions using polymers with standard flow properties and correlated Mold flow predictions with actual results from the injection molded part. • Special Projects: Changed the Mold Flow direction using ABS in AT & T Telephone housing for cost reduction and better parts. • ESD: Introduce the additive to the footwear Thermoplastics Compounds PRESENTATION:* MDSAP presentation at ASQ Worcester Chapter 2019 * Sterilization presentation at Intertek auditors Conference 2017 • Sterilization, SPE Conference, Ma 2007 • E-beam sterilization, Galway, Ireland. 2006 * ANTEC 2004 “Electron Beam Compatible Polymers” Chicago May 2004, US. • ANTEC technical paper was presented 1997 Toronto, Canada. • Engineers Week February 24, Plastics Museum. “ Aaron Industries Grinding and Compounding Operation”