Experience and Achievements

           1999–1989 Kendall HealthCare Products (TYCO Company)

           Especialidades Medicas Kenmex S.A. de C.V. Mesa de Otay, Tijuana  B.Cfa., Mexico

           Phone (66) 23-42-00 to 06, and (619) 661-6100

Quality Assurance Plant Manager (1999-1994)

• Business Activity: Hospital Products Manufacturing involving Processes as: Plastics Injection Molding; Extrusion; Manual, Automatic and Semi automatic assemblies; Radio Frequency plastics Sealing; Ultrasonic plastics Welding; Chemical Solvent Bonding; Controlled Drugs Handling and Storage (with Official Responsibility), Packaging Processes like Form, Fill and Seal Technologies, Breathing Bags and Polybags. Medical Areas include Urology, Anesthesia and Diagnostics, Wound Care, Respiratory Circuits, Silicone Catheters and General Care Kits. Everything under USA Official FDA (Food and Drugs Administration) Regulatory Regimentation and ISO 9000 / EN 46000 Certification Statements (Plant was ISO 9001 / EN 46001 Certified during my Administration in the QA Department and under my representative responsibility for the Quality System).

• Responsibility in Raw Materials, In-Process Product and Finished Goods Final Disposition.

• Responsibility in Inspection, Testing and Final Disposition of Finished Goods after Sterilization (EtO, Gamma, E-Beam).

• Plant Certification in ISO 9001 / EN 46001.

• Two FDA Audits, one with zero and the other one with few minor observations.

• Development of a Global Process Control ( called "X,Y,Z System", with the use of Statistical Tools) in through the Plant to involve all the Departments, resulting in the general knowledge of procedures, Quality conscience participation and continuos improvement in processes and departmental activities.

• Development of Quality Indexes, Reports and Interdepartmental Communication, with internal results of more than 300% improvement in defects and rejects rate decreasing.

• External Quality showing a decreasing of "Customer Complaints" in more than 100% rate.

• From Quality Engineering Area, a Development of a Procedure for "Projects Launching".

• Experience in Processes, Product, Machinery and Suppliers Validation, and alternatives to speeding efficiency and profitability.

              Decreasing in QA Departmental population in around 100%, and design of alternate functional activities for

             Efficiency and Profitability Improvement. From 115 to 65 people.

             Great participation in Cost Savings Projects.

                                                                                                                                                           More Experience

Music: You�re Still the one: Shania Twain