Supply chain

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• Accumulating required inputs for design documentation including Material Specifications, Purchase specifications and Drawings for company’s electromechanical products and Identify Critical to Quality (CTQ) and Critical to Safety (CTS) characteristics for products pertaining to product efficacy and patient safety. • Design quality plans to determine COC (Certificate of Conformance) and COA (Certificate of Analysis) requirements including CTQ’s and CTS’s as well as incoming inspection plan requirements. • Extensive experience with ISO-13485, ISO-14971 (Risk Management) GMPs, Statistical Process Control (SPC), DOEs, Gage R&R principles, Design /Process-Equipment Validation (IQ, OQ, PQ), Computer systems Validations, Periodic Reviews • Extensive medical device background and experience including document review, validations and verification, technical writing, quality system regulations, and risk management. • Experience in all aspects of quality control and quality assurance including conformance of quality system to FDA 21 CFR Part 820, Part 210, Part 211 and Part 11. • Certified Six Sigma Green Belt professional. • Significant experience establishing global quality management systems, inspection readiness, supplier quality management. • Determining AQL size for receiving lots depending upon Class of medical devices and risk involved in it. • Focused expertise in manufacturing quality, FDA audit management, compliance, internal, external, and supplier audit. • Analyzing and