Description
Summary: Technically sophisticated software developer and quality engineer with extensive knowledge of FDA Quality Systems Regulations (21 CFR 820) concerning development of medical devices, as well as principles of Good Manufacturing Practice (GMP). Adept at developing and selecting product-appropriate quality systems, flawlessly designing validation processes in precise alignment with quality requirements. Proven success in creating and delivering program and procedural training, liaising across the organization and leveraging superior communications acumen to forge cross-functional collaboration. Areas of Expertise: * Software development Lifecycle (SDLC) * Data analysis and report design/development * In depth knowledge and experience with rational databases/concepts and query tools * Design Development * Methodology * Regression testing * Scripting * Project Planning & Management * Business/System Requirement analysis * Best Practice Process Development * Risk Management & Mitigation * Quality Assurance & Control Strategies * ISO 13485 Quality Management Systems - Medical devices * ISO 14971:2007 Risk Management for Medical Devices * FDA Quality Systems Regulations (QSR) * SQL * JavaScript * C++
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