Bilingual, over 21 years of successful management experience in Quality Assurance in Healthcare and Pharmaceutical industries including development and implementation of complete quality systems per CFR 21: QSR, ISO 9000, ISO 13485 models, quality assurance systems, quality assessments, customer complaint handling, failure investigation analysis, preventive and corrective action implementation, supplier development, auditing. Certification and qualification, sterility assurance, process, equipment and tooling validation, testing fixture development, regulatory affairs, calibration and documentation controls, internal auditing, management reviews. Management experience in private industries up to 2,200 employees with responsibility of groups as large as 200. Management of Quality Systems (Quality System Administration), CE Mark experience, Training experience in Quality System Audits. Seven years of teaching experience at the Baja California State University / Tijuana Campus in quality control, SPC and statistical techniques. Extensive experience in quality assessment programs, sterility quality assurance. American Society of Quality Control Certified Quality Engineer (CQE) and Certified Quality Manager (CQM). Master Degree in Business Administration (MBA). Experience in processes and equipment transference from other locations. Experience in quality management programs for QSR compliance. Working knowledge of TQM, World Class Manufacturing Principles, Lean Manufacturing, Visual Manufacturing, Kaizen Programs, CAPA and CAT teams implementation and in the areas of injection molding, extrusion, anesthesia breathing circuits, anesthesia trays, silicon and PVC catheters, urinary bags and kits, Form /Fill/Seal operations, thermoforming operations, suction catheters, RF welding, ultrasonic welding, vibration welding, packaging validations, new materials validation, raw materials incoming inspection, process and product inspection.

Sr. Quality Manager @ Provides leadership and decision making to assure organizational compliance to defined company quality systems, FDA regulations, International regulatory requirements, industry standards and customer requirements. Leads and supports quality improvements to create or improve upon business and manufacturing processes. From July 2012 to Present (3 years 6 months) Tijuana Area, MexicoDirector QA/QC Operations @ Ensures compliance of the manufacturing sites and distribution centers, to applicable quality assurance standards and regulations; providing leadership and support to the local Operations organization to ensure products are manufactured and distributed in accordance with regulatory requirements and meet all regulatory requirements at level of site/country. Implement policies, goals and practices that promote and support the consistent achievement of quality and compliance objectives at the site for Manufacturing and Logistics locations and with Suppliers. Assure the consistent application of Manufacturing and Logistics QA best practices, and to implement improvements as needed, across all site. Ensure suppliers understand their role in providing quality and timely material to manufacturing site; ensure effective supplier audit programs. Ensure that site products are stored and distributed to customers according to regulations and procedures. From June 2008 to July 2012 (4 years 2 months) Quality Assurance Manager @ Overall control of the quality assurance / quality control and quality system activities. Responsible for the ETO, Radiation and e-Beam QA sterilization validation and control activities. Responsible for QC Incoming Inspection Activities. Preparation of QA Balanced Scorecard - Key Performance Indicators Monthly Report and its analysis to improve plant performance and for Quarterly Operations Review with Plant and Corporate Management. Coordination of global activities of the CAPA and Complaint Tracking Programs. Preparation of Monthly Complaint Trend Report and Analysis. Champion of SPC Implementation Program. Approval of product, processes changes, new product introductions and product transferences from other locations. Responsible of the Plant Calibration and Validation Programs. Responsible for the transition and certification of plant operation under ISO 9001/EN46001, ISO 13485:1996 and ISO 13485:2003 Quality Systems. Six Sigma Blue Belt Champion. From November 1989 to May 2008 (18 years 7 months) Quality Assurance Manager @ From 1989 to 2008 (19 years)

MBA, Administration @ National University From 1980 to 1982 Universidad Autónoma de Guadalajara From 1972 to 1976 Antonio Diaz is skilled in: Quality System, FDA, ISO, ISO 13485, Lean Manufacturing, Medical Devices, Injection Molding