SUMMARY

Education

Bachelor of Science, Electronic Engineering, BSEET

Software

DOS, MSWin 3.1, 95, 98, NT, XP, MS SQL Server, Mac OS, MSOffice, PageMaker, PhotoShop, MS-VB, Merant PVCS: Version Manager & Tracker, Telelogic - DOORS, SILK, Visual Test, Mann Man, Visio, Seapine - Test Track Pro, and numerous Internal proprietary Tracking Dbase’s

Professional Experience

Confidential, 6/07 – 05/09
Senior Software Supplier Quality Engineer, Assurance Engineering
Provided Supplier Quality Support for assessment of corporate external software suppliers involved in delivering either Software Development Services or Software Solutions

• Provided guidance to BSC facilities to develop individual expertise to support plant software assessment support
• Developed and refined software supplier assessment policies and procedures as needed to maintain compliance with changing industry and regulatory trends.
• Provided support to medical device development teams on complying with corporate and regulatory requirements.
• Assessed software development life cycle deliverables with external providers.
• Scrutinized external supplier’s software development validation deliverables for compliance with corporate and regulatory requirements.

Confidential, 1/04 – 9/06
Senior Software Quality Assurance Engineer, Research & Development (Contract)
Responsible for software test & compliance activities (systems & software) associated with In-Vitro Diagnostic (IVD)
Blood Gas Analyzers & Glucose / Lactate Meters (Class II) medical equipment. Software & Devices compliant. w/ISO9000/CE/GxP/21CFR part 11 requirements and QSR. Lead SQE on multiple V&V activities, including day to day V&V activities on multipliable product lines. Provided training to/and Direction to work multiple Engineers as
Assigned.

• Implemented Software Traceability and Software Defect Management Systems
• Software Verification & Validation Plans
• Software Test Plans
• Software Test Summary Reports
• Software Validation Protocols / Test Cases
• Software Traceability Matrixes (DOORS)
• Software FMEA’s
• OTS Documentation
• Design Reviews
• Code Reviews
• Software Compliance Activities
• All Compliance V&V activities

Confidential, 1/03 - 06/03
Senior Software Quality Assurance Engineer, Engineering Test (Contract)
Responsible for the running & reviewing of Software Validation Test Scripts on Medical Patient Monitoring Systems (Class II) medical device. Software & Devices compliant w/ISO9000/CE/GxP/21CFR part 11 requirements.

• Creating & Running of Validation Test Scripts (Manual & Automated)
• Capture & Tracking of Software Anomalies
• Reviewed validation documentation for completeness & compliance w/FDA – ISO9000

Senior Software Quality Engineer, Quality Assurance
Responsible for all software compliance activities (systems & software) associated with In-Vitro Diagnostic (IVD)
(Coagulation & Critical Care (Class II)) medical equipment. Software & Devices compliant w/ISO9000/CE/GxP/21CFR part 11 requirements.

• Performed Software Audits & Design Control Inspections on Design History Files (DHFs)
• Provide Support to R&D For ISO/FDA/3rd Party Inspections
• 3rd Party Software Project Reviews and Audits (nationally & internationally)
• FMEA Review & Approval
• Corporate Software ECN Approval Authorization
• Design Control Standard Operation Procedure (SOP) Creation, Review & Training
• Review & Approval of all (in-house R&D, Manufacturing & 3rd party) Software Life Cycle Documentation, i.e. SPMP, SCMP, SRS, SDD, STP, STR, Traceability, FMEAs etc
• Design Reviews & Phase Transition Reviews
• Program Wide Design Control Inspections

Confidential, 4/98 - 4/00
Senior Software Quality Engineer, Supervisor Software Quality and Test, Research & Development
Responsible for all software verification, validation and compliance activities associated with In-Vitro Diagnostic medical equipment in a cross function multi disciplined environment. (Coagulation & Critical Care (Class II)). Software & devices compliant w/ISO9000/CE/GxP/21CFR part 11 requirements. Supervised and directed 7 Technicians & Engineers involved with verification & validation testing of IVD instrumentation (computer systems & software). New Product Development & Sustaining Engineering Programs. Activities included but not limited to:

• Software Verification & Validation Plans (SV&VP)
• Software Test Plans (STP)
• Software Quality Plans (SQP)
• In-process Software and Design Control Audits
• Software Code Reviews
• Performed Program Wide Design Control Inspections
• Design Reviews & Phase Transition Reviews
• Program Phase Reviews
• Review & Approval of all (in-house & 3rd party) Software Life Cycle Documentation, i.e. SPMP, SCMP, SRS, SDD, STP, STR, Traceability, FMEAs etc…
• Software Configuration Management Administrator (PVCS Version Manager) (source code control)
• Software Defect Database Administrator (PVCS Tracker) (defect management)
• Requirements Management Administrator (QSS DOORS) Document Database (approvals, technical reviews, traceability, etc.)
• Software FMEA/Hazard Analysis Review & Approval
• Design Control Standard Operation Procedure (SOP) Creation, Review & Training
• Performed Software Audits & Design Control Inspections on Design History Files (DHFs)
• Provide Support to R&D For ISO/FDA/3rd Party Inspections (nationally & internationally)

Confidential,4/96 - 4/98
Senior Software Quality Engineer, Research & Development
Responsible for all software test and quality activities associated with medical devices used in laser vision correction. Devices compliant w/ISO9000/CE/GxP/21CFR part 11 requirements.

• Supervised and Directed Technical Writer and Testing Staff
• Responsible for the Complete Testing of two product lines
• Software Test Documentation Development i.e. Test Plans, Traceability Matrixes, Test Summary Reports etc.
• Wrote & Performed Software Validation Protocols & Test Cases
• ECO Kit Preparation

Confidential,4/96 - 4/98

• Senior Software Quality Engineer, Research & Development
• Software Labeling
• User Manual Validation, Review and Approval
• FMEA/FMECA Review & Approval

Confidential, 11/92 - 2/96
Technical Writer, Quality Systems Group
Provided ISO9001/9002 Technical Writing support to 25 Business Units within Polaroid Corporation. Support included:

• Compliance Consulting
• Internal Compliance Audits
• Standard Operating Procedure (SOP) Development
• Level II Inspection , Measurement & Test (I.M.T.) Instruction Development (complete w/photo’s and figures)
• Level III (forms & datasheets) Development
• IMT Date Base Development & Equipment Traceability

Confidential, 9/91 - 9/92
Product Specialist, Manufacturing Department
Responsible for investigating and performing root cause analysis on Sonos and Patriot ultrasound medical systems. System analysis included:

• Final System Testing and Defect Identification
• System Troubleshooting & Analysis
• Root Cause Analysis
• Component Level Troubleshooting & Repair
• Functional Board Test & Repair