Dallas Harris's Linkedin Analytics

Career oriented individual, with working knowledge of Worldwide Regulations, Standards and Quality Management Systems (QMS), currently employed as a Staff Quality Systems Engineer with DePuy Orthopedic in Warsaw Indiana. Over thirteen years experience working in the Medical Device field, with expertise in Quality System Management, Corrective and Preventive Action, Internal Audit, Document and Data Control, Change Control, and Supplier Audits. Comprehensive understanding of MDSAP Regulations, ISO 13485, FDA (21 CFR Part 820), MDD (93/42/EC), Japan Pharmaceutical Affairs Law (Ministerial Ordinance 169, 2004), Brazil Resolution No 59 (ANVISA-Brazil GMP) and CMDR (SOR/98-282). Experienced interfacing with Notified Bodies and FDA. Developed and implemented training programs for Internal Auditors. Comprehensive experience establishing and managing compliance with current regulations and standards including, MDSAP Regulations, CFR 820, 211, CMDR, MHLW Ord.169, ISO-13485, ISO-9000. Demonstrated success in effectively managing quality departments and cross-functional teams to assess, develop and implement quality management systems in a collaborative manner. Authored and implemented QMS documentation. Expertise includes: •Manufacturing / Process Controls •Design, Supplier and Controls •Corrective and Preventive Action •Quality Management Systems and Audit Processes •Process, Metrics/Data Analysis •QMS Requirements and Auditing Instructor •Project Management Motivated team player with demonstrated talent for deploying Quality & Regulatory requirements, quality tools, and upgrading and streamlining of processes. I am an enthusiastic self-starter who can boost productivity, foster efficiency, develop and deploy strategy for effective Quality Management Systems.