Quality Assurance Project

B renda LeBlanc

** ******* **** **** * Gardner, MA, 01440 u 978-***-**** u ******@***.***

SOFTWARE QUALITY ASSURANCE

Objective: During these times of a challenging economy and intense competition, releasing a

product / application to the market with a high degree of quality is essential . My experience within

a variety of industries, knowledge of FDA regulations (Medical Devices), various industry

standards and regulations, software auditing, and understanding of software development life-

cycles should benefit your company in its quest for quality.

Summary of Qualifications:

• A proactive, team player with the ability to work in dynamic environments.

• Oral and written presentation skills, effective listening, ability to develop proposals and

recommendations, effective facilitator and team builder.

• A wide degree of drive, initiative, creativity, and ability to tenaciously seek answers and

solutions.

o Strong work ethic, self-starter, creative, energetic, and enthusiastic

Professional Strengths:

• Quality Assurance / Software Quality Assurance

• Process Compliance Audits

• CAPA / Risk Assessment

Process Improvement/Lessons learned

•

• Excellent communication and interpersonal skills

• Object Oriented and Structured Analysis and Design technique models

Industry Regulations and Standards:

• FDA Quality Systems Regulations, Medical Device 21 CFR 820

• ISO Standards: 13485, 14971, and 9001

• International Traffic in Arms Regulations (ITAR)

• NASA-STD-8739.8, NASA Software Assurance Standard

• Export Administration Regulations (EAR)

• IEEE 829 and 730 Standards

• HIPPA Regulations

Compliance, Software, Test Tools:

• Standard Operating Procedures/ Process Directives/Work Instructions

• Requirement Traceability Matrix

Brenda LeBlanc

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10 Jackson Hill Road u Gardner, MA, 01440 u 978-***-**** u ******@***.***

• ClearCase, ClearQuest, SharePoint, DOORS, IRDM

• SVN, CVS

• Jira, Quality Center, Test Director

• Test Estimating Tools, Truth Tables, Project Plans, Checklists

Professional Experience:

Atmospheric and Environmental Research, Lexington, Massachusetts March 2010 - May 2011

Software Assurance Manager - individual contributor

Assigned to the Geostationary Operational Environmental Satellite (GOES-R) project as a member of the Mission

Assurance team.

• Performed formal Internal Process Compliance Audits (ISO 9001, NASA Software Assurance Standard

NASA-STD-8739.8, IEEE 829 and 730 Standards) to evaluate the effectiveness and ensure compliance to

GOES-R AER internal processes and core NASA processes including: Configuration and Data Management,

Change Management, Design Reviews, Peer Reviews, Requirements Analysis, Requirements Management,

Validation, Verification and Code and Unit Testing.

Identified and documented non-conformances, observations, and risks to the Project

o

Manager, and relevant stakeholders.

Verified / managed the resolution of non-conformances and escalated to the Project Manager

o

any issues that could not be resolved.

• Performed Product Assessments of GOES-R AER software documents, peer review packages,

Software Configuration Management work products and Test Results.

• Authored internal Standard Operation Procedures (SOPs) and Work Instructions including: Peer

Review, Non-conformance (CAPA), internal Process Compliance Audits, Product Assessments, Issue

/Problem Tracking and Software Requirements Analysis Process Directives.

• Provided support and oversight of Peer Review process (Software Requirements, Design and Code

and Unit Testing).

• Collected and analyzed Quality Trends and Metrics.

• Created/ facilitated Process Improvements and Lessons Learned training materials.

Boston Atlantic Technology, Westford, Massachusetts February 2008- March 2009

Software Quality Manager - individual contributor

Boston Atlantic Technology is a professional software consulting company specializing in the design and development

of software for medical device and healthcare related companies.

• Prepared FDA 510k Premarket Submission documents for the Luxtec 300 Watt Light Source

project (Class 1 type 'A' medical device). Documents included: Level of Concern, Device

Hazard Analysis, Software Requirements Specification, Requirements and Safety Traceability

Matrix, Validation Plan and Validation Test Cases.

• Performed validation testing (black box) on the Luxtec 300 Watt Light source. Reported and

tracked defects through resolution. Prepared and presented testing metrics.

• Authored SOP's for internal use by Boston Atlantic Technology staff that were compliant with

FDA's 21 CFR 820, the General Principles of Software Validation, ISO 13485, AAMI TIR

32:2004 and ISO 14971. SOP's included: Design Reviews, Software Design Transfer, Software

Requirements, Validation, Software Development, Software Risk Management, Software

Configuration Management, Software Problem Resolution, Software Tool Validation and

Verification.

• Authored Software Requirement Specification Documents, Requirement Traceability Matrixes,

and Test Cases for the IL's GEM 4K (Class 2 Medical Device) Operator Certification and Audit

Log features.

• Performed Audits of Boston Atlantic Technology's internal Processes. Identified and

documented non-conformances, observations, and risks.

• Designed a mentoring program for the SQA Lead and training programs for members of the

validation test team that addressed: Design Controls, Design Reviews, Requirement Analysis and

Traceability and Validation procedures as they related to 21CFR 820 and ISO 13485.

Workscape, Marlborough, Massachusetts July 2007 - September 2007

Software Quality Assurance Manager

Hired as a permanent employee to introduce change, methodology, process improvements and manage the

Compensation and Performance Solutions test team. Workscape’s Compensation Planning and Performance

Management Solutions allow global companies to identify, motivate, retain, and reward their employees.

• Analyzed Quality Assurance test preparation and test execution resource needs based on client

specific budgets, schedules, risks and priorities. Allocated SQA resource estimates to ensure end

to end test coverage.

• Mentored Quality Assurance resources and Business Analysts in writing and reviewing business

and functional requirements, functional, non-functional, GUI, performance, end to end,

OS/browser and security test cases, estimates and project plans.

Blue Cross Blue Shield of Massachusetts, Boston, Massachusetts December 2006- July 2007

Quality Assurance Test Lead (Contract position)

Assigned to the HCR Account Member Setup Project as the QA Lead. The HCR (Health Care Reform)

Account

Member Setup project’s scope included the automated set-up of individual members into individual unique accounts

and groups in order to comply with Massachusetts legislation that requires all Massachusetts residents have health

insurance as of 7/1/2007.

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10 Jackson Hill Road u Gardner, MA, 01440 u 978-***-**** u ******@***.***

• Created HCR Account Member Setup Test Strategy and Test Plan documents which were so

comprehensive that the BC/BS SQA director utilized them as the official prototypes for all other

SQA test teams.

• Introduced the concept and outlined the benefits of implementing 'end to end testing' (including

Mainframe and web based testing) which resulted in the Project Managers deciding to expand the

scope of the testing effort to include Billing and Claims.

Assigned to the Provider Portal Release 4 project as the QA Lead to ensure that the project was shipped with the

highest degree of quality. The overall purpose(s) of the Provider Portal Release 4 project was to enhance the Provider

Portal (Blue Links for Providers Portal) in order to simplify health care administration, enable quality improvements

and improve Provider satisfaction.

• Introduced and utilized detailed QA Test Estimates and Project Plans in order to allocate

appropriate time and resources for all test phases of the Project Life Cycle.

• Trained QA Test resources on the following: creating detailed end-to-end test cases, reviewing

software requirement, identifying missing and ambiguous requirements, and tracing requirements

to test cases.

MassMutual, Springfield, Massachusetts March 2006 – August 2006

Project Quality Manager (Contract position)

Assigned to the Broker View Project (one of MassMutual’s 6 most strategic projects for 2006) in the role of a Project

QA Manager.

• Played a critical role in helping the Distribution Common Service area of MassMutual identify

gaps in their current SDLC, implement SQA Process and mentor test managers. Proposed SQA

process improvements that the MassMutual Testing Center of Excellence board recommended to

be the standard for all SQA departments throughout MassMutual.

• Hands-on management style assisted business resource test team members in how to identify test

conditions, create comprehensive test cases (manual test cases) and trace requirements to the test

cases. Test cases covered the following: website functionality, navigation, security,

performance, ease of use and site content ensuring that the MassMutual Style Guide

requirements, Service Level Agreements, and Compliance Rules were met.

• Introduced the concept of risk-based testing which included: risk analysis, test planning and

estimating from which SQA Metrics and measurements were generated.

The Hanover Insurance Companies, Worcester, Massachusetts October 2004 - January 2006

Quality Assurance Lead (Contract to Perm)

Assigned as the QA Test Lead for the BOP Expansion Project. BOP Expansion Project (Business Owner Policies) was

a multi- phased project designated as the ‘most critical’ for 2004-2005 Commercial Lines.

• As the Test Lead of the ‘Best Practices Pilot' (ISO 9001) project, trained SQA Test Team

members in SQA Methodology and SQA deliverables. Defined and captured SQA Metrics for all

phases of the SQA process. As the technical lead for the project, defined SQA Entrance / Exit

criteria for each phase of the SDLC and provided continual risk analysis and risk assessments to

Senior Management.

• Used the Test Case Point Estimation Tool to create Test Preparation and Test Execution estimates

in order to effectively allocate on shore and off test resources and maintain the testing budget.

• Met with representatives from various downstream test groups to identify testing

concerns. Authored comprehensive Test Strategy and Test Plan documents that

identified complete end-to-end testing efforts (web-based, client server and mainframe

systems) for all test groups involved in the project.

• Tracked all issues and associated root cause that impacted the testing effort. Documented the

issues and associated root causes in the End of Test Summary Report. The issues captured were

used by Senior Management for process improvements to test regions, sharing test data across

test teams and end to end testing coverage.

• Performed black box testing on the new Agency Portal. Testing included: Functional, GUI and

Navigation testing.

JPMorgan Chase, Lowell, Massachusetts March 2001 – July 2004

Quality Assurance Lead

Originally hired as a permanent Quality Assurance Test Analyst and promoted to Quality Assurance Test Lead.

Assigned as the Team Lead of the Client Access Group. Led the testing effort of the JPMorgan ACCESS

Cash_Online application. JPMC online is a web based Cash Management application, which enables Customers to

obtain and process Cash, Trust and Investment Transactions.

• Pioneered innovative, team building and cross-functional training programs to improve workflow

efficiency, simplify process, and reduce operation cost.

• Designated as the Client Access QA Team CMM representative for all projects. Worked with

CMM training team to help train and implement CMM practices to all members of the Client

Access Test Teams.

• Defined, maintained and delivered test estimates, test preparation, test execution, defect metrics

and root cause data for all Client Access Applications to Senior Management. Information used

by Senior Management for staffing, planning and continual process improvements.

• Received various JPMorgan Service Star Awards for performance and leadership for the ACH

Upgrade, JPMorgan Portal Separation, 2004 Disaster Recovery testing effort and various BAU

projects.

• Sole test resource of the JPMorgan ACCESS web based Password Reset Applications. Reviewed

Functional and Design Specification documents. Identified test conditions and traced

requirements to test case.

• Verified Requirements followed JPMorgan ACCESS Style Guide and security requirements.

Performed Smoke, Functional, GUI, Regression, End to End and Production Verification testing .

Brenda LeBlanc

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10 Jackson Hill Road u Gardner, MA, 01440 u 978-***-**** u ******@***.***

Systems Engineer for Point of Sale platforms 1985 - 2001

Point of Sale Systems Engineer for various Point of Sale Vendors and retail companies including: Almys,

Bradlees, Star Market, GEAC, In-Store Systems.

• Duties included: testing various IBM 4680 and 4690 Point of Sales applications, Software coding

(IBM 4680 C Basic), Configuration Management, Software and Hardware installation and Help Desk

Support, Marketing Support, Training and Training material development.

Computer Skills:

•

• • Microsoft Access

Microsoft Word Microsoft Project

• • • Windows 95, 98, 200 XP

Microsoft Excel Visio

•

• Mozilla FireFox

Internet Explorer

Education:

Fitchburg State College, Fitchburg, Massachusetts - BS Degree, Business Administration

Concentration in Management, Magna Cum Laude

Mount Wachusett Community College, Gardner, Massachusetts - AA Degree, Liberal Studies

Phi Theta Kappa, High Honors

Currently taking Intermediate Java Programming class

Training:

• Software Development for Medical Device Manufacturers

• NASA Software Development

• CMM Level 3 training

Contact this candidate