Summary StatementVersatile Quality Manager with combined skills in quality management, auditing of processes, procedures and organizations. Skilled at providing effective and efficient systemic analysis of an organization related to their unique regulatory standards. Background includes certifications in ISO 9001-2008 by RAB, QSA, TS 16949, AS 9100 and ISO 13485 qualified Lead Auditor to perform internal audits. Strengths include managing internal and external auditing systems for both Medical Devices, and Automotive Component manufacturing. Experience managing employees in North America, Mexico, Europe and China. Key skills in:• Manufacturing Quality • Certified Six Sigma Black Belt• Production Control • Trained in Lean Manufacturing Systems• Reliability • Global Experience• Purchasing • Internal/External AuditingBack ground includes certifications inISO 9001-2008 by RAB QSATS 16949, AS 9100 and ISO 13485 qualified to do internal auditsKey skills includePerformed internal medical device audits in preperation for FDA directed audit. Pass FDA audit with no new 483Warring letter was lifted by FDA Managed internal and external auditing system in North America including MexicoAutomotive experience which spans assignments in the following areas manufacturing, quality,production control. reliability and purchasing Six Sigma Black Belt Lean Operations Systems TrainingSpecialties: Quailty & Business Systems Auditor.Supplier Quality Manager Quality Manager
Listed skills include Quality System, Quality Management, Six Sigma, Continuous Improvement, and 32 others.