Skill Set Summary
- ISO 13485, 10CFR50
- IEC 61508, 60601, SOX,
- IEEE1012, cGMP,
- Env. languages
- Oracle, SQL, PERL, JAVA, C , ETL, DW, Linux, EB, UML
- Test Management
- Functional, FAT, Spiral, Performance, Agile, DRB
- Project Management
- MS Project, Primavera, WBS, Earned Value, Utilization
- Req. Pro, ClearCase, DOORS, Selenium, QTP, ALM, Quality Center
- Process Developement
- SQAP, SVVP, Use Cases, Test Design, Scripting
- Hazard Analysis
- Risk and Criticality Analysis, FMEA
- Defect Management
- Priority/Severity Triage
- Tracking and Trending
Principal QA/Testing Consultant
Total Quality Management Lead Confidential
- Developed overall TQM/testing program for major integration project.
- Established consensus with senior management on TQM approach, creating assessment criteria, QA/test reporting and metrics as well as Continuous Improvement opportunities.
- Created goals and objectives based on consensus standards and best practices to determine deficiencies in process, ITIL Governance and proper SDLC implementation.
Principal V V Consultant Automation
- Oversaw all functional and recipe based protocols to support biologic drug development and manufacturing.
- Developed GDP and cGMP SOPS, validation of requirements traceability, production download verification and ECN closeout.
MDMS QA/V V Manager
- Developed comprehensive test strategy to automate the MDMS from front end customer service applications, ETL and batch processing and account databases in support of enhanced customer centric data.
- Performed test case reviews along with change control, release management, defect tracking and root cause analysis for triaged defects.
- Established enterprise code quality/complexity/function point breakdown using McCabe IQ.
Orange QA/RA Lead Medical Devices
- Developed and managed all aspects of the business, network/infrastructure and security compliance requirements for the Cardio Remote Monitoring System CRMS .
- Supported implementation of network event monitoring and all GPRS architecture impacts.
- Coordinated an internationally collocated project team 30 across Europe, Canada and the US.
- Led a range of multi-tiered projects including test development and coordination of onshore and offshore India support and performance.
- Developed and executed complex integration testing of functional and non-functional business requirements for software application and data bases resulting from new plan data schemas.
- Led the corporate implementation of desktop application functionality and performance.
- Conceived, developed and implemented the automation program for all IS project initiatives based on QTP and Selenium.
- Ensured that all automation work complies with enterprise and department frameworks, policies and procedures.
Principal V V Project Manager
- Developed the Requirements and V V program for high integrity non-safety and augmented safety systems.
- Conceived and performed proof of concept analysis on testing automation tools including strategy resource requirements and overall test program architecture.
- Implemented DOORS to establish baseline Requirements Traceability Matrix RTM from Contract requirements to SRS, SDD and Test Cases.
- Lead the development of the FMEA, Hazard, Risk and Criticality Analysis process for the I/A platform to establish baselines for Safety Integrity Level SIL 3.
- Established all training and qualification criteria along with driving the creation/modification of detailed processes, procedures and work instructions in order for staff to perform work.
Senior Technical Manager
- Created overall SIL 3 V V program for Delta V software modules, configuration and sequence of operations.
- Developed and/or validated all Safety Instrumented Systems SIS conditions for DCS Emerson Delta V safety system platform.
- Coordinated with DOE, engineering staff and QA to determine overall hardware requirements and safety classifications originating from Hazard Analysis and FMEA.
QA Engineering Supervisor
- Managed the AP1000 design, surveillance and procurement review process for code and compliance related to on-shore requirements of safety and non-safety systems.
- Responsible for overall project compliance to 10CFR50 App B, NQA-1, ISO 9001:2000, IAEA 50-C and HAF 003 requirements.
- Operated as Lead Auditor per ANSI/ASME N45.2.12 1977 and ASME NQA-1 1989 to qualify domestic and international supplier organizations.
- Established the Records Management process including network requirements and utilization of Documentum and eRoom.
- Developed the Construction Management Plan, Inspection Management Plan and related SOPs along with managed the NCR/CAR program and corresponding procedures.
Software SafetyProgram Coordinator
Led the I C Technical Specification and CGD program for the MOX project including resource management from project planning and scheduling to process development for multiple sites within the US as well as France and strategic partners.
Developed and implemented the requirements management program based on the Rational Unified Process RUP including Requisite Pro for all Criticality control safety systems.
Systems Test Lead
- Lead engineering staff 8 in process development and validation of ESF system per 10 CFR 50 Appendix B Requirements.
- Managed Project and WBS from Baseline to Project Completion P3e for all life-cycle documentation and traceability and testing.
- Designed and implemented a range of new test and system evaluation processes and procedures.
Manager, Test Automation
- Lead design of development and test systems for functional performance verification.
- Developed all procedures and GMP/ISO objectives within the test organization.
- Implemented SPC and Six Sigma methods in developing reliability tests, repeatability studies, and performance envelope characterization.
- Established budgeting, workflow breakdown, and outside contract requirements to meet project goals.