• Worked directly with principal scientists and quality engineering professionals with emphasis on assay qualification and investigation.• Executed verification and/or characterization protocols, analyzed data, wrote study summaries in accordance with governing procedures.• Independently performs complex test, quality controls, troubleshooting, maintenance and calibration of the Architect i1000SR analyzers.• Performed reagent and sample cross contamination verification testing and ELN documentation for HAVAB-G US, AFP, HS Troponin, PLGF, TSH, and HbA1c.• Performed investigation studies (Poly L Lycine, Line Diluent Washes) for HAVAB-G and AFP.

• Investigation, Review and Completion of all QA/Engineering Complaint Issues. Analysis tasks assigned utilizing various quality system inputs.• Reviewed individual complaints and associated service data to determine risk level and complete investigation into the “As Determined” problem and cause coding for each complaint.• Analyzed data from various quality inputs (including, but not limited to: nonconformance, FCA, complaints, MDR, etc) to determine trends and systemic issues. Prepared and issues reports based on information analysis.• Supported CAPA and maintenance activities for existing product lines.

• Assisted the Validation Quality Group in various areas: Statistical Data, Test Method and Process Validation.• Analyzed statistical clinical data produced and verified calculations, tables and graphs.• Simplified, analyzed, and reported data from several different sources.• Collaborated with the medical groups to complete joint scientific reports and FDA overviews.• Identified code and list information in order to implement the Utilization Database for specialized project for the FDA Audit.

Technical Support• Technical Acceptance of various models of handsets for Associated Carrier Group (ACG) regional carriers. • Assisted account team in technical support of regional CDMA wireless carriers for Mobile Devices Business.• Generated Change Request (CR) for approval of Product Release Instruction (PRI)/Operating System (Flex) configuration and customization of mobile devices.Product Specification Management• Resolved product compliance issues regarding the Restriction of Hazardous Substances (RoHS) directive.• Managed 500 files per month by upload of product specification environmental data from suppliers to internal database and provided support to other data managers.• Resolved daily resolution of Conditional Fail environmental data that required reviewing.• Administered support on technical or data quality issues stemming from systems upload, supplier data preparation, or product BOM reporting.• Determined electrical specification for legacy parts to include Pb-free solder requirements per the IPC/JEDEC J-STD-020B standard.

Packaging Test Engineer Technician 02/1998 - 02/2006• Worked directly with engineers and quality assurance with emphasis on product qualifications, equipment calibrations/validation, and document change control.• Managed/Coordinated all aspects of product testing by verifying protocols, analyzing and generating reports. time management manage electronic documentation records.• Initiated CAPA concerning issue related to Product testing, equipment calibration and operating produces.• Trained co-workers in initiating Electronic Calibration Requests, (ECAR’s), ICAS, IDOC, and instrument usage and reviewing operating procedures/policies.• Achieved 5% cost reduction initiating 70 Electronic Calibration Requests (ECAR’s) by deactivating instruments that would have required calibration.• Conducted multiple tests such as plastics, labels, barcode, liquid, cartons, corrugates, induction seals, IV bags, insulated shippers, and medical devices by following SOP, OP, EOP, GMP, GLP and ASTM standards. • Used AutoCAD to make modifications to packaging/product drawings.Facility Designer- 02/1993 to 02/1998• Experience in AutoCAD, MicroStation, Project Architect, & Microsoft Suite. Responsible for graphic design (presentation drawings), architectural, electrical, mechanical, and HVAC engineering drawings.• Established a drawing numbering system in order to maintain all past and current drawings that are required to meet the needs of the FDA. • Developed 500 mechanical piping and manufacturing floor layout drawings for the FDA submission in the period of 6 months.

• Experienced in AutoCAD and MicroStation; Responsible for graphic design (presentation drawings), architectural, electrical, mechanical, and HVAC engineering drawings.

• Experienced in AutoCAD, MicroStation; Responsible for graphic design (presentation drawings), Civil, architectural, electrical, mechanical, and HVAC engineering drawings.