James C. Mack

***** ******** ******* *****; Indianapolis Indiana 46234

224-***-****; acvhx9@r.postjobfree.com

OBJECTIVES: To direct Quality Assurance efforts within an organization and provide a strong contribution to corporate goals through experienced leadership, improving operations/processes/workflows, communicating clearly, sharing with peers, team development, and individual mentoring, while continuing growth of professional skills.

TECHNICAL SKILLS & EXPERIENCES SUMMARY (Well Over 20 Years of Experience):

Organizations Supported: Baxter, Abbott, Motorola, Siemens, Hines VA Engineering, Pharmedium, AstraZeneca, Johnson & Johnson, GP Strategies Consulting, Cubist, ThermoFisher, Teva Israel, Boston Scientific, Astellas, Merck, General Dynamics Electric Boat, ASHP, Hewitt Associate, CitiGroup, Trane, VisionTek, Cherry Electrical.

Job Titles and Positions Held: Software Quality Assurance Manager, Business Architect, IT Project Manager & PM/Tech Writer, IT/IS Quality Manager & Compliance, Quality Assurance Project Manager, Manager/Business System Analyst in Engineering Operations, Project Manager, Software Quality Assurance/Lead /Engineer/Validation Resource, Business System Analyst, Setup Specialist Level 2 Project Manager, Lead Software Test Engineer, Systems Analyst, Software/Hardware Engineer, Co-Electronic Laboratory Manager and Software, Firmware & Hardware Test Engineer, Senior Engineering Analyst, Electronic Designer, Electronic Team Lead and Electronic Technician.

Trained In and Executed To: Various Organizational SDLC Models (Waterfall, V Model, Iterative, and Spiral models), Information System Project Delivery Methodology (ISPDM), Various ISO 900X, Application Lifecycle Management (ALM), Agile Methods, FDA (CFR 21 part 11, 210, 211 & 820), Annex 11, GAMP 4 & 5, GxP (GDP, GLP, GMP…), DEA/FDA guidelines dealing with Form 222 (1305 and 1311), European ENs, CISPR, Baxter’s 19 Quality Specification, Abbott’s Software Quality Assurance Programming (SQAP), QS9000 (automotive), IEC 61000, EMC, CE Mark, SIX SIGMA Production & Process, UL Standards, ARI Standards and various organization’s SOPs/WIs.

Validation/Testing Supported: Black Box, White Box, Ad-Hoc, Boundary, Limit, Integration, Load/Stress, Risk Base, GxP, Non-GxP, Regression Testing, Firmware and Hardware (from Charter Start-Up to Production Go Live).

Document Types Supported: Created, Edited, Enhanced, Reviewed and/or Used – Visio Business Process Flow Diagrams Change Management Forms/Systems, Standard Operation Procedures (SOP), Work Instructions (WI), Statement of Work (SOW), Project Plan, Configuration Management Plan, Software/Technical/Detail Design Specification (SDS/TDS/DDS/DS), Application/Software Risk Analyst, Validation Plan, User Requirements Specification (URS), Functional Requirements Specification (FRS) and System Requirements Specification (SRS), Requirements Risk Assessment, Test/Qualification Plan/Protocol/Procedure/Specification, Trace Matrix Specification (TMS/TM), Various Gate/Check Points Check Lists, Test Case (Installation (IQ), Operational Qualification (OQ), Performance Qualification (PQ) User Acceptance Testing (UAT), Evaluation/Ad-Hoc and Use Cases), Test/Qualification Reports, Validation Summary Report (VSR), Test Closure Memo, Software Release Communication Memos, Various Training Documents/Materials (for Projects & Program Managers, Testers, Analysts, Tech/Customer Support, Laboratory and Production Workers) and Gap/Risk Analysis (Forms, Documents and Reports with Suggested Enhancements to Product and/or Supporting Documents & Requirements).

Software System Validated: Document Management Systems, Custom Developed Applications, Commercial off the Shelf (COTS) or Out of the Box (OOTB) Applications, Quality Management Systems, Change Management (CM)/Change Control Systems, Web Based Internal/External Systems, Various SAP/SaaS Systems, Financial/Data Management, Enterprise Resource Planning (ERP), Customer Relationship Management (CRM), Laboratory/Clinical Systems, Learning Management System (LMS), HR Benefits Systems and Excel Spreadsheets/Forms/Reports.

Application Supported/Used: SharePoint with E-Sig Add-Ons, Documentum, AEGIS, MetaPhase, Teamcenter, Teamcenter NX ILas, Blood Bank Management System, Clinical Decision Support (CDS), Quality Tracking System (QTS), TrackWise, FirstDoc, Prosonify, infoMaestro, MKS for CM, HP Quality Center, SuccessFactors LMS, ATC Retail, Win-Dat, Basic, COBOL, FORTRAN, C++, Visual C++, Visual Basic, SQL scripting, Latter Logic, MMI, PLC, GAL, LON, AccessDirect, XML, XML Spy, XSLT, Most MicroSoft Applications, QuickPlace Source Safe, PVCS Tracker, Word Perfect, Corel Draws, Lotus Notes, Fox Pro, SmartLink, Tellme ORCAD, P-CAD, CADNETIX and many more…

EXPERIENCE:

03/2016 – 06/2016 General Dynamic Electric Boat / IT Convergence, Groton, Connecticut (Contractor of Bridgepoint)

My assignments as Senior Quality Assurance - Testing Consultant of the IPDE group.

Create process controls materials, provide guidance and direction to support the process controls being implemented for the creation of nuclear submarine components.

Include and support with process controls per governmental guidelines within the Teamcenter / Teamcenter NX application usage that would translate in to Procedures, Standards, Manuals, Work Instructions and Training Materials.

Create or facilitate the creation of various quality / validation templates (such as: Planning, Requirements, Design, Testing, Go-Live Ongoing Support and Periodic Reviews).

Facilitate the creation as needed and/or required of the various quality / validation templates.

Review prior to approvals and use of all finalized drafts of quality / validation documentation.

Support the change control process and various work orders that are tied into the current existing change control process.

10/2014 – 03/2016 GP Stategies, Columbia, Maryland (6 Month Contract to Full Time Contract Employee)

My assignments as Software Quality Assurance Manager of the Technology Integration and Implementation, Enterprise Technology Solutions group.

Provide Quality Assurance guidance, training and leadership to the Technology Integration and Implementation, Enterprise Technology Solutions group of our SDLC process and validation.

Manage and support SDLC validations efforts of the main custom application within our group.

Improve the Validation Tool Kit (VTK) deliverables for SuccessFactors LMS product as contracted.

As required assist in the product development of our group’s medical communication core product.

When working with Pharmaceutical Organizations, take the Validation Lead role and support/assist in the management of SDLC processes and deliverables for GP Strategies from SOW to Go-Live.

Assist in the validation, management, facilitation and testing/verification of all items listed above as required to achieve due dates and successful Go-Live(s).

Support all CAPA item discovered during client vendor audits in order to support continuity with the Pharmaceutical organizations that may have findings with our core SaaS product.

03/2014 – 10/2014 American Society of Health-System Pharmacists (ASHP), Bethesda, Maryland (Temporary Contract)

My assignments as Business Architect within the Operation and Technology Department to provide training and support to other Business Architects, IT Members and Internal Business Departments within ASHP.

Working as an IT Program Director organizing and implementing Software Development Life Cycle (SDLC) process and SIX Sigma business level methods with the Operation and Technology department as well as with the 10 internal ASHP business departments.

Interviewing business departments for processes while building business process flow diagrams (High Level and Low Level).

Guide the various Departments in the Creation of Standard Operating Procedure (SOP) as well as help them to understand the need for SOPs.

Collect requirements for User Requirements Specification (URS) from Accreditation, Finance and Marketing and Sales departments.

Train Business Architects in collecting Requirements as well as in the concepts and guidelines surrounding writing requirements.

Provide suggestions, guidance, direction and support when taking them through a solution-ing process when discussing possible software and hardware options during process improvement activities.

Provided instruction and rules for testing/verifying processes, tools and applications to the IT Department and the various Business Departments.

07/2013 – 12/2013 Johnson & Johnson - DePuy-Synthes, West Chester, Pennsylvania (3 Months Contract lasted 5 Months Contract)

My assignments as IT Project Manager & PM/Tech Writer Support within the GRQP IT/Compliance Department providing leadership guidance while sometime creating, reviewing and completing SDLC deliverables for multiple departments worldwide.

Responsible for the creation and completion of all SDLC project related deliverables for various groups and departments.

Provide support as needed when support for that role is not supported or is lacking such as a Business System Analyst (BSA/BA)/System Analyst (SA), Subject Matter Expert (SME), Technical Writer, Test Engineer and Test Executer for validation within the SDLC process for GxP software, firmware, hardware equipment and business process.

Responsible for the creation, modification and review support of business related documents such as SOP, Work Instruction, URS, FRS, TDS various security documentation from a corporate and compliance perspective.

Responsible for the creation, modification of existing, review, dry runs and execution of all validation deliverable such as IQ, OQ, PQ and UAT from a validated GxP perspective.

Support the remediation efforts of CAPA related events across multiple departments (such as: compliance, business, manufacturing and laboratory).

Support all ongoing remediation efforts that have been identified by the various management groups and departments worldwide.

Responsible for providing training as well as training materials for various groups and departments.

Provided guidance and assisted in the creation of our Teams SharePoint projects and deliverables sites with metrics on team’s projects, tasks, activities and statuses.

04/2011 – 07/2013 AstraZeneca - MedImmune, Gaithersburg, Maryland (6 Months Contract lasted 2 Years and 3 Months)

My assignments as IT/IS Quality Manager (ISQM) within the IT/IS Quality and Compliance Department was to support multiple projects in varying roles depending on size and resource availability with in the SDLC process.

Overall responsibility was to provide compliance guidance and training for any project teams that we were assigned to us while working hand and hand with the project team’s Project Manager to assure that there are no compliance issue when delivering systems for the various groups in the organization.

Provide training to any new Program/Project Managers on SDLC ISPDM processes and general corporate SOPs from a compliance perspective within GAMP, FDA 21 CFR part 11 & 820 guidelines to assure that the appropriate project deliverables are designed and implemented for a project.

Quality Manager’s are required members and approvers of the Change Approval Board and the Operational Readiness Review board meetings of any software/hardware change.

Provides Project Manager Leadership on a project that does not have a Project Manager assigned to the project in order to assure that project deliverables and time lines are meet.

Perform Business Analyst as well as Validation/Test Lead roles for GxP and Non-GxP applications when none exist in a project team for requirements gathering, validation, verification, qualification and general testing activities.

When resources were lacking ISQMs would assist in the creation, modification, review, dry runs and execution of all validation deliverable such as IQ, OQ, PQ and UAT from a non-validated and validated GxP application systems and/or programs.

Created and managed our IS/IT Quality Manager Teams SharePoint sites and provided ongoing reports with metrics on team’s projects, tasks, activities and statuses.

Responsible for the creation and review support of corporate SOP and Work Instructions from a compliance perspective.

11/2010 – 04/2011 Abbott Laboratories, Abbott Park, Illinois (3 Months Contract lasted 5 Months)

My assignments as a Manager/Business System Analyst within Engineering Operations was to support multiple projects while providing multiple roles support within Abbott.

Working as a Manager with Abbott management teams on future SDLC projects assigned to me from Phase 0 (feasibility, budgets and initial time estimations of projects) of Project Plan.

Working with the SBI group during initial requirement gathering and managed/confirmed the collection of User Requirement Specification (URS) and Functional Requirement Specification (FRS).

While working in the Business System Analyst (BSA) role, I also managed the validation process with the development team Software Installation Qualification (SIQ/IQ) to validation of the software Operation Qualification (OQ) as well as the business group User Acceptance Test (UAT). (I was also the Validation Lead and sometimes the sole Validation Resource as well on small projects I managed.)

Performed/assist when necessary, System Architectural reviews approvals and feedback to the development and/or business teams.

Research and recommend Commercial off the Shelf (COTS/OTS) application for business needs and arranged application demos with question and answer meeting of the Off the Shelf application when time allows.

Provided/facilitated training and/or managed of training when necessary after a new software package was purchased, developed, configured, validated and ready to be moved to production.

Responsible for Validation Change Request (VCR) Projects, Final Package and Document Review Close-Outs with the Business Teams and the Abbott Compliance Group.

Work with FDA 21 CFR part 11 guidelines with electronic signature guidelines to assure that the appropriate components are designed and implemented into the project.

06/2006 – 10/2010 Baxter, Round Lake and then to Vernon Hills, Illinois (6 Months Contract lasted 4 Years 5 Months)

My many assignments as a Software Quality Assurance/Validation Resource, Business System Analyst and Team Lead with Baxter’s R&D/QA/CA Portfolio Group on multiple projects in varying roles.

Worked on Baxter Product Lifecycle Management System Teamcenter Deployment Project and help assist / lead with the rest of the team documentation.

Lead validation efforts in the Application Migration from Acxiom Data Center to IBM Data Center.

Lead validation efforts in the Data Migration effort/tools/process from Metaphase and to Teamcenter.

Work on Quality Tracking System (QTS) team with TrackWise application with Baxter’s configurations/customizations as a BSA and Validation Resource.

Work on BaxEDGE team using FirstDoc application with Baxter’s configurations/customizations.

Created/Assist in the Creation/Approval of various validation deliverables, design and building of required configuration (e.g. Validation Plan, Qualification Protocal, User Requirements, Functional Specification(s), Design Specification(s), Installation (IQ), Operational Qualification (OQ), Performance Qualification (PQ) User Acceptance Testing (UAT), Trace Matrix, Interim Report, Final Report…).

Create, Review (pre-execution) and Approval (post-execution) of test cases as technical resource.

Assist and help coordinate the creation, pre-execution approval, execution, post-review, and post-execution approval of test cases.

Work with FDA 21 CFR part 11 guidelines with electronic signature guidelines to assure that the appropriate components are designed and implemented into the project.

Responsibilities defined as needed for assisting in the creation, management and/or maintenance of the validation deliverables during the releases for multiple projects.

Assist in the interview process when needed.

01/2006 – 6/2006 Pharmedium LLC, Lake Forest, Illinois (3 Months Contract lasted 6 Months)

My assignment as a Software Quality Assurance Manager/Lead with the Information Technology Department.

Worked with and manage Developers, Project Manager and/or Project Lead, Validation Resource, Business Unit/Production and Marketing group to lead Software Development and Go-Live efforts.

Collect business requirements for the projects that were underdevelopment and starting to go through development.

Wrote test scripts for manual testing trough out the software development life cycle and help executing test scripts while following “The Good Documentation Process”. (When the main push was over; I created the process for them to follow for quality and software development.)

Worked with central operations group in creating Standard Operating Procedures (SOP) dealing with software development and integrating the software into the production facilities hardware that they are currently or would be working with.

Worked with Pharmedium on improving the processes in the productions centers from an IT perspective by traveling there, going through the design process on the fly, testing on the spot while put together recommendations on how to get better out put through automations.

Worked with them to help them get past some of there DEA and FDA regulatory compliance issues that they currently have against them.

12/2004 – 01/2006 Hines VA (EDS), Hines, Illinois (6 Months Contract, lasting 1 Year and 1 Month)

My assignment as a Software Quality Assurance Analyst with the Blood Bank Management Team.

Management Controls

oAssist with the BBM internal audit process and respond to internal audit findings.

oResearch, develop, apply, and ensure that the BBM team follows appropriate VA, VHA, VistA, FDA (CFR part 820), and blood bank accreditation agency documentation standards.

oProvide status reports to the BBM PM in a timely manner.

oProvide primary or backup support for:

Maintaining and monitoring the action-item database.

Coordinating and leading meetings and providing reports, as required.

oFollowing up with BBM team members, as required

Design Controls

oDevelop test plans, protocols, and scripts that exercise applicable software functionality requirements.

oPerform internal system testing.

oAssist with alpha and beta testing of BBM software.

oReview and edit online help text.

oConduct a quality assurance review of BBM work products.

oConduct phase reviews, as required, during software development.

oProduce other documents, as required.

CAPA Controls

oAnalyze CAPA data at regular intervals to facilitate system improvement.

oPerform, track, and review tasks related to the CAPA process, including Medical Device Report(ing) (MDR) evaluations, Corrections and Removals (CAR) reports, complaint investigations, deviation requests, and change requests.

Production and Process Controls

oCreate master test plans for software testing.

oAssist with the creation and maintenance of the (DMR).

Document Controls

oAssist with the development of BBM Installation/Operation/Performance (IOP) test cases.

12/2003 – 02/2004 CITIGROUP, Deerfield, Illinois (3 1/2 Months Contract, lasting 2 Months, Assignment was Canceled)

My main assignment as a Quality Assurance Project Manager with the Software Development Team.

Used Mercury Test Director Version 7.6 to create, execute and track the test cases.

Provide complex consulting and liaison activities between the business unit and technology.

Create FTP Scripts\FTP Test Scripts based on business requirements and functional specifications within the mainframe environment.

Assist the business in coordinating final phases of development, testing and implementation.

Write test scenarios and document test results.

Execute Operational System, Quality Assurance, and User Acceptance test plans.

Work with clients to certify them on Citi Group’s exciting products.

Communicate to the business the core products and how they interface with clients.

Trouble Shooting Clients Issues.

Working on Management documents to assure the paper trail is accurate and completed.

04/2003 – 08/2003 ABBOTT LABORATORY CORPORATION, Waukegan, Illinois (3 Months Contract, lasted 4 Months)

My main assignment was as a Systems Analyst to work with Abbott’s GTS Software development team.

Wrote Functional Requirements Specifications, Software Design Description and other supporting documentation while following Abbott’s SQAP process for the Unique Person Identifier Application.

Worked with FDA 21 CFR part 11 guidelines with electronic signature guidelines to assure that the appropriate components are design and implemented into the project.

Communicated with different areas to assure the completeness and quality of the Software being design.

Translated business process and its requirements into a business solution for software development.

Created models for business process; reconcile process and data models.

Prepared strategic business requirements; use SDLC methodologies, and toolsets.

Fully utilize data and process modeling techniques along with workflow analysis techniques.

Consulted with customer and systems personnel to determine the type of information to be processed.

Devised usable data verification methods and standard systems procedures requirements for testing.

Defined and analyze needs and information for requirements.

Prepared charts, tables, and diagrams to assist in analyzing problems, utilizing various businesses.

10/2002 – 03/2003 HEWITT ASSOCIATE, Lincolnshire, Illinois

My main assignment was as a Setup Specialist Level 2 Project Manager working with different internal Client Teams Development Groups to provide and managed/customized Medical, Dental, Vision and Health Care services/benefits/coverage for companies across the United States.

Explored new technologies while conducting analysis regarding client business requirements and care services that will enhance the customer experience in HR and benefits delivery.

Maintained the ongoing application and facilitating ongoing change management. Analyze and setup new requirements and version management.

Fostered continuous improvement of the technical efficiency of the AccessDirect application which customized the Health Care and Benefits services of that company.

Worked closely with the Requirements Specialist, our Clients and Client Teams to analyze and setup AccessDirect voice and web application for initial implementation of these benefits and services.

Prepared and actively participated in leading client scoping and requirements conversations and create the appropriate technical documentation for those discussions.

Participated in follow-up meetings; worked closely with the Requirements Specialist to define AccessDirect technical requirements as well as other client interactions.

Served as an integration point between AccessDirect technical resources, the TBA Client Delivery team, AccessDirect data exchange team and other Hewitt technical resources related to AccessDirect.

02/2000 – 11/2001 SIEMENS BUILDING TECHNOLOGY, Buffalo Grove, Illinois (6 Months Contract, lasted 21 Months)

My main assignment was as a QA Software Test Engineer Working with Siemen’s Engineering Development Group for environmental control systems.

Created a Gap Analysis tool using Excel to track the Test Specifications and Test Procedures coverage and Sub Requirements found in Design Specification Procedures.

Worked closely with various engineering development teams to created Test Specification and Test Procedures/Cases (IQ, OQ and PQ) for custom Workstation Program as well as Software and Hardware testing and validation of Firmware for environmental control systems when requirements or design specifications were lacking to assure compete testing and test coverage of product.

Provided Training for the QA Testers on the product, testing tools and in executing the test procedure for the different parts of the product that was under test as well as personally executing various Test Procedure to help the testing effort in maintaining time lines.

Performed audits on the technicians to assure that the processes and procedures were being followed.

11/1999 – 02/2000 MOTOROLA (Automotive), North Brook, Illinois (3 Months Contract, lasted 4 Months)

My main assignment was as a Software/Hardware Engineer to work with Motorola’s Testing Group and Engineering Group.

Worked with EMC Reliability Development Group, testing new and existing product as well as other issue with existing product dealing with susceptibility and/or emission.

Developed New Test Plans, Test Software and Hardware Test Racks for the Automotive Testing that meets QS9000 guide lines for automotive and the various IEC 61000 guidelines and EN.

08/1999 – 11/1999 ABBOTT LABORATORY CORPORATION, North Chicago, Illinois (Month to Month Contract)

My main assignment was as a Software Quality Assurance Engineer to work with Abbott’s ILAS Software validation team.

Created and Performed Gap Analysis on Test Plans and Developed Software before it could be released (which also included a complete gap analysis with FDA CFR 21 part 11) and adding the appropriate components to fill the gaps found.

Used Test Director and Win Runner programs to look over Test Sets and Test Cases (OQ and PQ) for the Gap Analysis.

Wrote, developed, improved and implemented existing and new Test Plans and Procedures/Cases changes to assure product completion.

Helped define and redefine requirements when necessary; when there were none or lacking of.

Performed audits to assure that the documentation test protocols with the test tools were in place.

10/1998 – 04/1999 BAXTER CORPORATION, Round Lake, Illinois (3 Months Contract, lasted 7, they sold the group)

My main assignment was as a Lead Software Test Engineer to work with Baxter’s ATC Retail.

Wrote, developed, improved and implemented existing and new Test Plans and Test Cases/Procedures (IQ,OQ and PQ), while adhering to guidelines dealing with FDA CFR 21 part 11.

Helped define and redefine requirements when necessary; when there were none or lack of.

Worked on analyzing any mechanical, electrical and electronic hardware issues that came up.

Worked closely with the different software engineers to work thru, finish the bug fixes and to drive the product to final release.

Handled problems with alpha and beta sites testing and/or setups when necessary.

Performed audits on the test protocols and procedures to assure that our processes and procedures are in place and are being followed.

08/1998 – 10/1998 MOTOROLA (Cellular), Libertyville, Illinois (3 Months Contract, lasted 3 Months)

My main assignment was as a Hardware/Software Test Engineer to work with Motorola’s Cellular Research Group.

Worked with the European Groups to solve recurring problems that May exist mainly over seas, dealing with EMC Compliance Testing and other quality issues.

Performed audits and/or mock audits on the different setups to assure that the processes and/or procedures were correct and being followed for the data that was needed to be collected.

06/1996 – 07/1998 THE TRANE CORPORATION, Lacrosse, Wisconsin (12 Months Contract, lasted 25 Months)

My main assignment was as a Co-Electronic Laboratory Manager and Software, Firmware & Hardware Test Engineer to work with The Trane /American Standards Corporation and the different business units across the United States and Overseas.

Supported EMC Compliance Testing and different standards such as, UL, FDA, CE and the different EN’s that drive CE, FCC, CISPR, as well as ARI and other standards as needed; managed the sound and vibration test group.

Used and helped refine a custom in house system called Win-Dat; write Visual Basics program modules to work with Win-Dat.

Worked with the main Engineering Group and the Electronic Laboratory test and evaluation group to ensure the test plans and setup are designed, equipment purchased and/or executed correctly.

Wrote official Trane Test Procedures/Work Instruction and Create Forms and Documents to support ISO 9000 for engineering and the test groups (We passed on our first try after 18 months of starting this effort).

Introduced and created internal design rules/procedures for Trane engineering to assist in passing FDA CFR 21 part 11 guidelines and dealing with electronic signature.

Was responsible for the design, documenting, implementation and training on test racks for the Test Lab as well as adhere to ISO 9000 program, processes and procedures, while adhering to guidelines dealing with FDA CFR 21 part 11 for medical facilities.

Created/Performed audits and/or mock audits to assure that our processes and procedures were in place.

09/1995 – 06/1996 VISIONTEK, Gurnee, Illinois

Senior Engineering Analyst (02/1996 – 06/1996) and was Engineering Analyst (09/1995 – 02/1996)

Handled all technical issues and support to the California Engineering Group and Managed/Lead the other Engineering Analyst (Software, Firmware and Hardware).

Assisted Engineers on major tasks and in new product design for customers.

Resolved technical issues, which are initiated by Purchasing, Manufacturing, Testing and Engineering.

Debugged and analyze designs as part of qualification prior to manufacturing.

Supervised Engineering Analysts and Test Engineers to assure proper qualifications of designs.

Designed various test systems for reliability studies mostly using bed of nail test system while using specialized testing tools/system.

Wrote official Test Procedures, Work Instruction and Create Forms and Documents to support ISO 9000 (We wrote and passed on our first try after 6 months of starting this effort).

Went to customer sites to resolve

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