Quality Assurance Project
Resume:
Macedon NY
Qa_excellence@yahoo.
com
Cherie Ehlers
Professiona
l Accomplished Quality Assurance professional with 18 years of experience
Overview in Testing, Audit, Regulatory Compliance, and Quality Assurance.
Seasoned audit professional who has audited companies for compliance and
conformance with ISO, CMMI, HIPAA, FDA and DOT guidelines as well as
internal process and procedure adherence. Sitting for the Certified
Relevant Quality Manager through the American Society for Quality (ASQ) exam in
Skills June 2013. Invaluable experience in the Healthcare, Information
Technology, Mass Transit and Manufacturing industries. Expert in
End-to-End testing, Requirements Definition, Requirements Management,
Process Documentation and Metrics. Agile Scrum Master and fully versed
in Waterfall SDLC.
Proficient in Microsoft Office (Word, Excel, PowerPoint)
Experience Experience with TriZetto Facets
Automated Testing
Testing .NET, C# and Java applications
Manual testing experience
Agile SDLC expert
SQL scripting
HIPAA documentation expert
Creating Processes and Procedures
Metrics definition, gathering and reporting
Capability Maturity Model Integrated (CMMI) experience
Documentation of Test Plans, Steps, Protocols
Project management tools
510K Application support
Lean Six Sigma Green Belt (Xerox)
IQ/OQ/PQ testing
CGMP experience
Training & Mentoring
CAR/PAR
MTTR/FMEA
DMAIC
Experience with SaaS
Experience in ITIL
IQ/OQ/PQ
1/2012 - Present Quality Assurance Manager eHealth
Technologies
Responsibilities include Documenting processes and procedures,
developing the QA Manual, driving SSAE16 (SOC3) compliance. Testing
cutting edge (.Net) referral management system software to enable
medical image transfer and DICOM image retrieval. Performing internal
and external audits for quality and regulatory compliance.
Ensure that testing activities will allow applications to meet business
requirements and systems goals, fulfill end-user requirements, and
identify and resolve systems issues.
Application testing for healthcare related services employing a modular,
agile approach while using black-box and white-box methodologies.
Collaborate with analysts, designers, and system owners in the testing
of C# and .NET software applications and integrations.
Create and execute Software Test Plans.
Process documentation creation and responsible for HIPAA and SOC3
(SSAE16) compliance.
Perform software, security, compliance audits.
Provide QA management and guidance for client proposals (RFI, RFP, SOW).
Drive the testing effort by determining acceptance during the
requirements and analysis phases.
Review and analyze the effectiveness and efficiency of existing systems
and develop testing strategies for improving or leveraging these
systems.
Requirements development and project direction using TeamPulse,
Sharepoint and other project management tools.
Creating test cases and the environment in Team Foundation Server (TFS).
Take an active role in cross-departmental projects, project management,
technical customer support, and other Information Technology duties as
needed in this small, dynamic environment.
Establish and implement policies, procedures, and technologies to ensure
server and data security including appropriate documentation and
training guides.
6/2009 - Present Senior Consultant WBI Inc.
Responsibilities include creating business plans and providing quality
direction to client companies. Subcontract management for international
project. Created (TAA) Technical Assistance Agreements and applicable
export licenses (ITAR/EAR) required for international commerce.
Providing direction for quality processes and procedures. Developing
master test plans, procedures, protocols and test cases. Developing
automated testing scripts using SQL, QTP, Mercury Interactive products
(Loadrunner/Winrunner). Setting metrics and ROI goals. Cutting test
cycle costs by 20% (fourth quarter). Translating the "Voice of the
Customer" into requirements and department direction. Developing and
training DFx concepts to quality and manufacturing departments.
Developing Quality Manuals, process and procedures. Supporting ISO
re-certification. Select achievements include:
Defining, capturing and reporting Metrics within complex organizations.
Conducted quality and compliance audits.
Developing and instituting a process improvement program that slashed
$60K USD from manufacturing costs.
Improved overall product/manufacturing from usability of 82ppm to 98ppm
through deployment of quality methodology and instituting IQ/OQ/PQ
program.
Utilized source selection evaluation criteria and Six Sigma tools to
reduce new supplier risk from 45% to 20%.
Using Microsoft Project to coordinate projects, budgets, time and
materials.
Developed (RFP) Request For Proposal processes. Conducted a RFI phase to
reduce candidate field to four viable sources down from 18+ sources.
Developed Black Belt project teams to attack company overruns and
identify opportunities.
Lead SAP teams to test and deploy SAP modules BW, HR, FI.
Defined the R&R and RACI for a dynamic bank client.
Conducted Verification and Validation testing on a variety of software
projects.
Created entire testing lifecycle for multipurpose printing device (end
to end).
Defined Agile SDLC and assisted project manager with SCRUM and
estimation activities.
Created automated testing scripts and ran testing cases through
Loadrunner/Winrunner tools.
6/2010 - 9/2010 Senior Test Lead Healthnow
(BCBS)
Responsibilities include managing the test team to deliver Change
Enrollment to production environment. Provide metrics and project
accountability to senior staff. Manage the requirements clarification
process for the test team. Defined, coordinated and trained staff on
quality methodologies, test case preparation and execution. Train test
team on Quality Center (v 9.2 and 10). Selected activities include:
Using TriZetto Facets v4.41 to test in QA environment and Dev
environment 6659 files with updated and Overlay data.
Created Change Enrollment Test Plan, Verification and Validation plans
and executed the plans.
Managing a team of 5 test engineers, 2 performance engineers and 3
functional testers.
Created SQL scripts to verify data populating the WIP.
Created test metrics and reported metrics to PM on project.
Tested embedded real time software using C++ and C#.
Processing all IAM requests for team.
FTP dat files and processing them into 6659 file format.
Creating all testing data files for Version 2 formatting utilized HTML,
HTTP and XML.
Created automated and manual test cases in Quality Center for Load &
Validate, iLog, Inventory & Transaction Management.
3/2008 - 5/2009 Sr. SW Process Improvement Engineer FESI Fuji
Film
Recruited to assist company in acquiring CMMI Level 2 maturity through
the SEI. Acted as facilitator and Special Interest Group (SIG) lead for
Risk Management, Process and Product Quality Assurance, Project
Planning, Project Monitoring and Control, and Configuration Management.
Participate in Requirements Development and Requirements Management.
Responsible for auditing projects to process guidelines and compliance.
Created support evidence and actively participated in SCAMPI B
assessment. Tailored several operating procedures to meet the needs of
the organization. Selected achievements include:
Lead all of my SIG's to successful completion, no SIG required a second
instantiation.
Maintained a Process Asset Library.
Created numerous process work products, swim lanes and assistive tools.
Created PIID's for several projects undergoing assessment.
Participated in SEPG.
Assisted test team in creating test specifications, peer reviewing those
specifications and documenting the testing performance.
Mentored staff in learning project management skills and applications
including estimation, work load, impediments and the use of automated
test tools.
Assisted in developing the Software Development Lifecycle for the
organization.
Defined and deployed Risk management strategies held several Risk
assessment meetings and ensured follow through on realized risks.
Developed training materials and conducted training for entire
organization.
4/2006-3/2008 Sr. SW Quality Engineer/ Technical Lead Real
Time Enterprises (RTEmd)
Recruited to provide Quality Assurance support for cutting edge Nuclear
Magnetic Resonance device. Developed MV&VP, Overarching Strategy,
Verification Procedures and support for client as well as
subcontractors. Responsible for entire project quality as well as
implementation and compliance with FDA and HIPAA regulations. Created
and controlled project software requirements, configuration management
and timelines. Responsible for instructing and ensuring compliance to
the quality system. Implement structure to support DHF.
Performed all GD&T testing on final products.
Provide audit oversight and CAR support for laboratory cGMP/GXP/GLP
regulations.
Responsible for creating CPARs, Audit Reports, Checklists, and FAT/SAT
documentation.
Maintain and service Nuclear Magnetic Resonance IVDD (Cryogenics,
desiccant).
Performed receiving inspection for all third party items.
Develop issue/error reporting tool and database.
Used a variety of Micrometers, Calipers, Gages and hardware testing
equipment. Kept equipment compliant.
Ran entire testing/quality assurance program for all software and COTS
applications including multi-location (New York, North Carolina, New
Hampshire) failover testing.
Created and executed automated OO scripting using Winrunner/Loadrunner,
QTP, and Silktest to enhance testing performance where applicable.
Used SQL Test Case Builder and Performance Analyzer to simulate
production environment testing.
Performed full cycle Verification and Validation testing and reporting.
Provide training and support for all EPA/ISO/FDA/OSHA/cGMP/EHS.
Created Master Test Plan, Test Procedures, Protocols and Defect Reports.
Setup and ran CMM equipment.
Acted as the Single Point of contact between the Executive Management
team and Quality team members.
Responsible for extrapolating the performance data from the IVDD and
macro to identify timing irregularities and determine process flow
bottlenecks.
Responsible for delivering the complete Project Plan with total
supporting data that includes Status reports, Issues Log, Performance
testing Matrix, Detailed Testing Reports, to both Executive and Senior
Management.
3/2005-4/2006 Sr. Software Quality Engineer Johnson & Johnson
OCD
Recruited to provide requirements traceability for multi-million dollar
Pre-Market submission of Immunodiagnostic/Immunohematology equipment.
Assist stakeholders in identifying and managing risks, implement
escalation and communication plans and to manage sponsor expectations
appropriately. Ensures the effective development and utilization of
project documentation, including the implementation and compliance with
FDA and HIPAA regulations.
Responsible for building OAPDs for HBc and Chagas assays.
Project lead for VITROS ECi V 3.1 release.
Involved in 510K submission for new assay development.
Performed all aspects of Verification/Validation testing.
Created several automated testing scripts to run through system
diagnostic testing and web based stress testing.
Controlled project requirements, scope, and change management issues
following CAPA guidelines.
Used SQL Test Case Builder and Performance Analyzer to simulate
production environment testing.
Utilized Silk Test to create automated testing scripts.
Entered in product data to ERP systems and managed manufacturing send
off.
Established and collected metrics for all testing activities.
Actively participated in Risk assessment, mitigation and escalation.
Verification & Validation activities.
CRM duties for varied BioPharm projects.
Responsible for auditing and compliance to 21CFR part 11 and part 50
standards.
Responsible for cGMP/GXP/GLP.
Involved in creating FDA compliant documentation and ensured compliance
with FDA, CGP and ISO standards.
Utilizing Requisite Pro to document project requirements, traceability
and metrics.
4/2003-2/2005 Quality Assurance Specialist ALSTOM
Signaling, Inc.,
Recruited initially to provide international support for implementation
of Quality activities. (CMM, ISO, CENELEC). Managed SCB and Software
Config. Mgmnt.. Testing in Unix/Windows/Web environment. Assist division
wide successful audit to CMM Level 2. Duties included all automated
testing using WinRunner and LoadRunner products.
Developed and tested SQL script solutions for SQL 2000 and SQL 2005.
Implemented international IT system between Novatris (France) and Harris
Interactive (HTML, HTTP protocols).
Performed all GD&T and final production clearance using Gages and state
of the art optical surfacing equipment.
Tested embedded software systems that supported survey applications.
Audited manufacturing division to compliance with IPC-A-610.
Tested complex C++, .NET and OOS products, White/Black/Grey box testing.
Six Sigma project definition and solution.
Championed FMEA project team.
Developed and implemented objective metrics report for 25 IT reportable
operations.
Hardware testing on advanced microprocessor based Cab signaling systems,
fire detection, CCTV and maintenance services on railway fixed
machinery.
Coordinated and controlled various Quality Certification and Improvement
programs (CMM L2, ISO, KAIZEN, Six Sigma).
Administrated SAP system for CRM, PD, Financials, Warehouse.
Analyzed scheduling metrics and developed an estimation method with 85%
accuracy, first implementation.
1996-4/2003 Quality Assurance (HW,SW) Xerox
Corporation
Recruited initially to test complex products ranging in value from $1
Million to $35 Million. Accountable for total Subcontract performance
(Quality, Cost, Sched./Del., and Tech. Perf.) Created process/procedures
for Subcontractor selection, Solicitation, and Negotiation.
Involved in successful CMM audits of Level 4 in Brazil, Level 5 in
India, and Level 2 in the US. Ensured compliance to J STD 001.
Selected and applied appropriate tools to accurately estimate and plan
the work of project groups within agreed policies.
Produced work plans according to required standards.
SCM for all software products in Brazil.
Responsible for metrics identification, benchmark and reporting.
Assisted in the recruitment of Quality Assurance Department personnel.
Lead team of quality specialists in FMEA, MTBF and MTTR identification
for manufacturing equipment.
Responsible for all records of compliance with IPC-A-610.
Purchase and procurement of lab equipment, development and
implementation of quality systems.
Responsible for Total Quality Performance on numerous printer lines
including NC60, Blackbird, Tigris.
Created test plans, test cases, defect reports and resolution reports
for issues found while product was in testing cycle.
Performed GAP analysis for printer features to ensure commonality
between product lines and created documentation to support master
feature list.
Slashed testing costs 15%, shipping costs 40%, and labor 17% while
delivering a 20% increase in productivity.
Performed all hardware final inspection testing on assigned product
lines.
Coordinated testing of $65 million worth of business equipment between
North and South America while implementing a process improvement plan
which cut re-work by 38%.
1989-1996 Helpdesk/Editorial Department
Thomson Professional Publishing
Provided deskside support for users of Mac, Windows, Unix operating
systems.
Edited and proofread complex legal documentation.
Trained end users on software and hardware applications.
Operated Kurzweil scanning equipment.
Performed verification and validation activities.
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