Utilizing Global Service Management System to accept issues, determine if they were safety related, escalate them to Quality Management (QM) for potential medical device reporting, medical device reporting, and investigation by Headquarter Support Center (HSC).• Serving as a Subject Matter Expert for the complaint handling process. • Providing complaint handling and quality engineering expertise and consultation to significant / complex projects.• Escalating incomplete or overdue complaint investigation and resolution tasks to the management of the responsible task owner• Contributing to product safety, product quality, and customer satisfaction related decisions (both data-based and risk-assessment-based decisions).• Ensuring prompt escalation and complete documentation of product safety complaints by requesting feedback to regional units as needed. • Ensuring complaint documentation and records are complete and in compliance with regulatory requirements prior to closure.

• Utilizing Global Service Management System to accept issues, determine if they were safety related, escalate them to Quality Management (QM) for potential medical device reporting, and investigation by Headquarter Support Center (HSC).• Serving as a Subject Matter Expert for the complaint handling process. • Providing complaint handling and quality engineering expertise and consultation to significant / complex projects.• Escalating incomplete or overdue complaint investigation and resolution tasks to the management of the responsible task owner• Contributing to product safety, product quality, and customer satisfaction related decisions (both data-based and risk-assessment-based decisions).• Ensuring prompt escalation and complete documentation of product safety complaints by requesting feedback to regional units as needed. • Ensuring complaint documentation and records are complete and in compliance with regulatory requirements prior to closure.

Signed one doctor contract as a Stem Cell treatment advocate promoting Adipose tissue isolation of patient's stem cells and used to cure/ relieve chronic conditions such as arthritis, joint injuries, stroke, Parkinson's, M.S., Muscular Dystrophy, and A.L.S (Lou Gehrig's Disease).As English speaking hiring manager, hired one Business Development Representative, interviewed four potential candidates, and responded to over twenty interested candidates.

• Invited to speak at 20TH Software Design for Medical Devices, for a panel discussion on Incorporating Human Factors & Usability into Marketable Medical Devices to Ensure Product Success. Spoke on Considering FDA and World Usability Regulations in Software Verification Testing.• Provided work reports and input as Verification Representative at Project Management meetings. Reported meeting results to supervisor.• Clarified bug reporting and determined severity levels at Software Change Review Board meetings.• Added 15% new information to Software Requirements documents, test plans, and test design documents authored by co-workers and wrote new feature requirements, test plans, and test designs.• Authored new protocol and performed Sample Tracking and Language Test cases for multiple builds which allowed for release in one year. • Acted as Technical Expert for software installation instruction Test Plans and Test Reports for Product Support involving printers and keyboards and aided in testing.• Tested three builds of Method Deletion Utility software led to release one month early.• Performed multiple software build regression testing for ADVIA 1200 and 1650 for six month release.• Wrote bug fix and new feature test cases for ADVIA 1800 and 2400 Analyzers, supervised and trained one other engineer, and released the software in ten months. • Assisted in testing the Operator’s guide and Online help in multiple languages for the Customer Documentation department cut estimated completion time by half.• Released XPT software one month early by performance of Calibration, General Enhancement, UI enhancement, and Regression test cases on multiple software versions.

• Recommended by manager for permanent position as Software Engineer based on work results, technical knowledge, and supervision/training of Engineers. • Reported Error causation in (FRACAS) during baseline reliability study on XPT systems aided in the instrument release in one year and six months. • Worked with JEOL Instrument Engineers and Software Engineers on Reagent Inventory errors. Issue was successfully fixed and verification performed.• Accomplished Customer simulation stress testing of the XPT Chemistry systems by utilizing WorkCell, Universal Rack Handler, LineMaster, and Centralink Software for sample delivery, processing and database/ordering led to reliability growth studies.. • Effectively performed Centaur XP instruments baseline reliability study which led to Reliability Growth Testing on software, hardware, and component upgraded XPT Centaur Immunology system and release one year and six months later.

• Exchanged testing methods in Japan for seven weeks. Immediately tested updates as were written by JEOL software programmers led to 50% increase in build release. • Tested interactions of LIS with ADVIA Chemistry Analyzers and provided feedback which led to a 25% increase in test efficiency.• Wrote and performed General and UI enhancement testing, performed Regression testing on multiple software versions, and wrote new protocol and performed Stress Testing on the database which led to release in one year. • Authored and performed new feature calibration testing on ADVIA 1650, 1800, and 2400 Analyzers which led to precise bug reporting, faster developer fixes, and fix verification.• Verified Test Definition software installation and build using comparison software in UNIX and Microsoft OS for Centaur CP, XP, and Classic Immunology Analyzers. All versions tested were released on time.

• Tested ADVIA 2400 70ml reagent containers for pipet errors due to reagent tray revolution speed which led to testing concentrated reagent packs and subsequent release of 15 new assays. • Developed new contamination set for one test due to saline diluent causing errant values every third sample which began study of all therapeutic drugs assays to determine contamination settings. • Determined Rerun dilutions on ADVIA 1200 Analyzer for over 20 assays transferred from ADVIA 1650 Analyzer.• Extended linearity range of Multi-standard calibration so error rate was within 5% acceptance range• Resolved linearity issue using IMS reagents mixed versus ADVIA reagents which led to release of new version of one blood and urine chemistry assay test. • Studied current Prozone setting and developed new settings for two tests to correct hook effect produced when sample concentration oversaturated reagent concentration.• Performed lot to lot reagent correlation and linearity studies led to release of 25 new blood and urine chemistry assays. • Optimized Parameters of over 20 already released assays on ADVIA 1200, 1650, and 2400 Chemistry Analyzers led to subsequent release.

Head of quality control for the synthesis of DNA using computer automated systems (Perseptive Biosystems 2 and 16 port synthesizers). Prepared various media, reagents, and solutions needed for the production of DNA sequences. Entered and edited sequences and prepared membranes for synthesis. Operated Clinical/Research lab equipment (vacuum centrifuges, UV-vis spectrophotometer, Polyacrylamide gel electrophoresis (PAGE), and other bench top instruments). Conducted the purchasing of lab supplies using websites and ordering by telephone. Resolved inventory control issues with contracted vendors.Entered and shipped outgoing orders using FedEx PowerShip and Airborne Libra systems. Invoiced the outgoing orders using Microsoft Access and made new databases as customer workload increased. Printed weekly and monthly reports to keep track of forecasted business.Accounts receivable using Microsoft Excel, Access, and Credit Card programs. Dealt with customers paying their bills and negotiating new contracts for them. One contract was for $200,000 per year.

Responsibilities included the upkeep of animals in a research facility.Worked with Lab Coordinator to check in the animals.Handled inventory control issues. Purchased lab supplies and instruments by calling the respective companies and ordering whatever was required.Provided professional feedback on the test subjects.Maintained an accurate log of the testing criteria.

Researched the affect of free radicals on heparin and related polysaccharides via size exclusion chromatography and structural determination. Tested different sizes for clotting factor activity in order to determine the smallest size capable of clot prevention with one factor or clot breakup with another.Prepared various media, reagents, and solutions needed for the operation of the lab.Conducted Clinical/Research lab procedures (Liquid Chromatography, HPLC, Amino Acid Analysis, UV-vis spectroscopy, and Polyacrylamide gel electrophoresis (PAGE). Operated Clinical/Research Systems, lab equipment (vacuum centrifuges, lyophilizer and other bench top instruments). Dealt with inventory control issues by working with Lab Coordinators.Performed equipment upkeep and ordered lab supplies.