Job Information
UNIVERSITY OF TEXAS AT ARLINGTON Quality amp; Regulatory Affairs Analyst in Arlington, Texas
The Quality and Regulatory Affairs Analyst delivers hands-on quality management and regulatory affairs solutions to a wide range of businesses including manufacturing, distribution, logistics, construction, health care, and government. Contribute to TMACand#x2019;s wide array of services that accelerate profitable growth and competitiveness ofTexas manufacturing by developing and improving profits, products,processes, technologies, and people..Generate leads, conduct assessments, prepare proposals, andsupport events.Assist with the implementation of various ISO standards (ISO 9001, AS 9100, ISO 13485, ISO 14971, FDA Requirements (Good Manufacturing Practices and#x2013; GMP and Good Laboratory Practices and#x2013; GLP), and Production Part Approval Process (PPAP) for TMAC customers in various industries.Customize the implementation process to meet the specific needs of each organization.Provide comprehensive training and coaching to customers on ISO standards and best practices.Conduct internal audits to assess compliance with ISO standards.Identify areas for improvement and provide actionable recommendations.Assist companies in preparing for ISO certification audits, ensuring all necessary criteria are met.Integrate knowledge, culture, and governance in deployments.Quality Improvement process solutions techniques, such as Strategic Planning, CAPA, and Risk assessment, training.Conduct audits, generate audit reports, and assist customers with follow up on the audit results.Assist with project implementations.Earn advanced and/or multiple certifications as required.Manage accounts having multiple projects across multiple product lines.Demonstrate effective project execution, project management, project results, and customer follow-up.Identify the financial impact of projects upon completion.Performs other duties assigned..Bachelorand#x2019;s degree in science, technology, engineering, math (STEM), or related field.Minimum of two (2) years of experience in manufacturing, quality consulting, or a related field.Proficiency in MS Office Suite..Masterand#x2019;s degree in science, technology, engineering, math (STEM), or related field.Two (2) years of experience in manufacturing, quality consulting, or a related field. Experience using Salesforce.Preferred certifications:and#xA0;Lead auditor (AS9100, ISO 13485, ISO 9001), European UnionMedical Device Regulation, Lean Six Sigma Black Belt