Keli Mcleod Email & Phone Number

Award-Winning IT and Quality Compliance Expert with 20+ years of experience delivering expertise to world-class companies including Fortune 500 Medical Device/Pharmaceutical leaders Johnson & Johnson and McKesson. Consistently expanding business and leadership skills through continuing education including Master of Science in Organizational Leadership. Key areas of strength include:• Software Quality Engineer (SQE): 1) Lead compliance workstream for FDA regulated (21 CFR Part 11, 210, 211, 212, 820) non-product computer systems such as LIMS, CTMS, TMF, ERP, CAPA, LMS, and QMS computer systems. 2) Complete Software as a Medical Device (SaMD) coursework in IEC 62304 (Medical device software - Software life cycle processes), ISO 13485 (Medical devices - Quality management systems), ISO 14971 (Medical devices - Application of risk management to medical devices), and Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions to become knowledgeable in SaMD.• Quality Auditor: Execute internal audits, data center audits, and software supplier audits including planning, authoring audit documents, monitoring, and reporting.• Business Process Improvement Manager: Collaborate with internal departments to identify business process gaps using Six Sigma Green Belt tools such as process mapping, process analysis, and process optimization.• Business Requirements Analyst: Build relationships with multiple stakeholders to identify computer system functional/non-functional requirements and prioritize requirements using MoSCoW Prioritization Model.• Project Manager: Manage enterprise projects using Agile/Waterfall project life cycle to track completion of project tasks, negotiate team problems, and communicate with management.

Listed skills include Six Sigma, Information Technology, Design Control, Clinical Trials, and 26 others.