Quality Assurance, Quality Management, Project Management

TODD R. EULER

*** ********** ****

Larkspur, CO *0118

303-***-**** - Cell

abgntc@r.postjobfree.com

Qualifications for Quality Management Leader

~ PROFESSIONAL PROFILE ~

. Dedicated career professional providing Quality Management services to

medical device, pharmaceutical, healthcare and information technology

companies; including expertise in FDA regulations, ISO standards and

CMMI.

. Dynamic leader and team builder, consistently motivating individuals and

teams toward success.

. Develops and implements Quality Systems that increases the efficiency,

reliability and confidence in Requirements Management, Design Controls,

Program Management and Testing Excellence for software and hardware

systems.

. Solid background in program management/operations, with over 15 years in

a management/leadership role.

. Highly knowledgeable in systems and software engineering, including

developing and presenting employee and customer training programs.

PROFESSIONAL EXPERIENCE

Senior Software Quality Engineer / QA/RA

MEDTRONIC, INC - SURGICAL TECHNOLOGIES, Louisville, CO - October, 2010 to

November, 2014

Responsible for leading the system level software quality engineering and

product management activities for Surgical Navigation projects with a

primary focus on neurosurgical solutions. Manages cross-functional

coordination and leadership using the Quality System to ensure adherence to

Design Controls, Regulatory Compliance and Business Processes.

. Managed change acceleration program that introduced Quality Audit

Checklists that facilitated cross-functional expectations, increased team

consistency and reduced document review/approval cycles.

. Using Service Leadership; coordinated an effort to improve product

accuracy and reliability (DFSS) through engineering and testing by

encouraging test and systems engineering collaboration and enhanced

engineering strategies.

. Responsible for planning and implementing Continuous Process Improvement

by balancing best practice business process efficiencies, including DFSS,

while maintaining compliance with Title 21 CFR Part 820 (Quality System

Regulation), EN ISO 13485 (Quality System), EN ISO 14971 (Risk

Management), EN 62304 (Quality System) and EN 62366 (Usability).

. Initiated, trained and lead CMMI-IDEAL approach for SDLC process

improvement and Kaizen/Deming PDCA to support cyclical continuous process

improvement.

. Provided liaison sponsorship of guidance development for Test Engineering

that identified key activities and documentation improvements that

contributed to improved quality in DHF artifacts.

. Received public and peer recognition for significant team contribution by

delivering calm, controlled and directed leadership during multiple

product development phases.

Principal Consultant / Consulting Director, Quality Management and Client

Services

QUALITY MANAGEMENT SYSTEMS CONSULTING, Denver, CO - February, 2009 to July,

2011

Committed professional providing quality assurance services to the medical

device, DoD, non-profit and start-up businesses. Responsible for designing

and implementing quality process systems for the lifecycle of software

products. Delivering quality related services including test planning and

analysis, test management, contingency planning, hazard analysis, test

development and test automation for clientele.

. Providing Quality Audit Oversight of the design, development, test, and

market release of software used in both surgical navigation applications

and other medical devices.

. Active implementation of FDA QSR, Medical Device Directive, ISO

13485,14971 and 62304 standards in a medical device environment.

. Worked closely with dedicated executives to describe, design and develop

a world class client service system integrating insurance provider

underwriting and benefits management with a complete payroll solution.

. Lead business analysis and requirements meetings with primary

stakeholders in order to coordinate an agile development process.

. Conducted Data Security Audits to ensure compliance with PCI and HIPAA

standards throughout development and implementation.

. Established multi-office security standards for DoD based business.

. Conducted large scale data conversions across CRM systems for a non-

profit organization.

~ Medtronic, Inc. / SQA Services / Self-Employed Business Solutions /

ProActive Advisors / Missions Ministries / Aqwest ~

Director - Quality Assurance and Testing / Engineering

CONFIGURESOFT (Now VMWare), Colorado Springs, CO - October, 2003 to

October, 2008

Provide direction of the quality engineering functions for an industry

leading enterprise configuration management provider enabling IT Operations

to deliver automated, secure and compliant services across its customer

base. Directly responsible for the development, implementation and

maintenance of the quality test program for the Center for Policy and

Compliance which provides toolkits for security, regulatory and operational

standards such as PCI DSS, SOX, HIPAA, GLBA, FISMA, and NIST.

. Directed a staff of 22 Quality Assurance professionals overseeing and

proving the highest standards of data, functional, security and

performance quality.

. Launched an Offshore Resource Center in Cochabamba, Bolivia paired with

local test development staff responsible for the successful Automated

Test Development Program that reduced time to market by over 38% and

establishing a predictable schedule for development deliveries and

product releases.

. Quality Liaison for offshore development team in India responsible for

oversight of deliverables to home office.

. Directed coordination of configuration management, build and test

automation in order to ensure working build delivery and consistent

product release cycles.

. Managed over 20 consecutive programs with organized quality teams

allowing for optimal coverage while providing opportunities for

individual career growth.

. Established processes and procedures to implement repeatable quality

testing process by introducing metrics, quality documentation, and

reassigning responsibilities.

. Provided department progress statistics towards company objectives

including ROI, effort vs. savings, and cost of quality over time.

. Established and directed the data quality standards system that supports

data analysis and accuracy analysis of source and output data that

supports daily statistical reporting to staff and customers.

. Implemented the Performance Quality Program that introduced continuous

testing of GA product to improve all aspects of product quality for

subsequent releases and patches.

. Develop and maintain an employee-training program to improve skills and

abilities of the Quality Assurance departmental staff and external staff

requiring Quality Assurance knowledge.

Senior Manager - Quality Assurance and Testing

AT&T BROADBAND, Denver, CO - March, 2001 to December, 2002

Provide leadership and daily management of the Quality Assurance and

Testing department of the Enterprise Development and Data Warehouse

business units. Work with and support peers and others throughout the

organization to ensure that quality is considered in a cost-effective

manner throughout the organization. Develop and maintain constructive

relationships with customers at all levels to manage quality expectations

and report data quality metrics. Develop, formulate, deploy and direct

quality programs involving specifications, standards, metrics,

documentation, and methodologies. Personally ensure the continuing review

of the Quality Management System and the formulation of new or revised

procedures to effect improvements, reduce costs, and enhance efficiency of

quality on a company-wide basis.

. Managed staff of Quality Assurance professionals responsible for

developing and maintaining the Quality Management System for Decision

Support Services and testing of all associated projects.

. Responsible for decommission of 28 legacy projects and replacement their

functionality which is producing a $10 million savings annually.

. Responsible for the implementation and management of all Quality

Processes and Methodologies in support of company operations.

. Managed and approved the reporting of test results, monitors status of

known defects, administered quality implementation in software design,

testing methods and procedures.

. Ensure that departmental personnel are trained to perform their jobs

effectively, including company policies and procedures as well as in all

quality processes.

Senior Managing Consultant / Owner

QUALITY MANAGEMENT SYSTEMS CONSULTING, Denver, CO - January, 2000 to March,

2001

Provide systems analysis, quality management and service management

services to industry leading businesses. Coordinated and implemented six-

sigma based knowledge transfer program.

. Developed and managed QA department of 18 responsible for delivering

multiple DSL Ordering/Provisioning products for internal and external

customers.

. Directed corporate participation in the development and implementation of

a corporate Quality Process System based on the SEI CMMI-SW, including

the creation of templates, customization of SDLC activities and employee

training.

. Provided Quality Assurance Analyst services developing and implementing a

quality process to establish specific entry and exit criteria and key

practices and activities for the Integration/System Test and User

Acceptance Test groups.

. Established the Systems Integrity Department, which included developing

the Unit Test, Integration Test, Problem Management, Release Management,

Partner Integration Test and Process Assurance groups.

. Developed a step-by-step approach for integrating Software Measurement

tools into the Software Process.

~ Metastorm / TestMasters, Inc. / ProtoTest, LLC / Rhythms NetConnections,

Inc. ~

Project Manager / Consultant

COTELLIGENT, Denver, CO - June, 1998 to January, 2000

Responsible for managing Software Quality Assurance for the compliance of

company medical information products, data warehousing and financial

software. Developed and maintained project plans, test processes,

compliance standards, acceptance criteria, test templates and project

schedules and budgets. Designed and implemented a company-wide project to

develop and maintain contingency plans to mitigate and proactively react to

potential Year 2000 and overall business risks.

. Managed multiple groups (4-12) of software engineers and associated

managers to produce customer driven software applications for multi-

platform products and internal tools to meet the long-term SQA goals of

the company.

. Developed automated software testing scripts using Mercury WinRunner and

Rational SQA Robot on Windows, IBM MVS/CICS, SUN Solaris Intranet and

Alpha NT Intranet platforms.

. Created and published process documents and software testing templates

used to establish consistency and repeatability in the software testing

process.

. Responsible for external audit preparation and management, which produced

minimal observations and recognition for industry 'Best Practices'.

~ MICROMEDEX, Inc. ~

Consultant / Manager, Software Development and Quality Assurance / Program

Manager

SYSTEMS RESEARCH GROUP, Denver, CO - April, 1996 to June, 1998

Responsible for planning, implementing and tracking multiple projects for

software development and software verification and validation activities.

Created documentation and validation methodologies of quality systems and

software for medical device and high technology firms. Trained management

and employees on computer system and software use.

. Managed Software Quality Assurance team of 16 individuals and directed

activities to respond to and successfully repeal FDA warning letters

issued under Title 21 CFR, Part 820. Our efforts received recognition and

are used by the FDA as examples of quality standards.

. Documented company procedures for software verification and validation

and Year 2000 compliance.

. Project manager for multiple software quality and Year 2000 projects with

completion of all projects on time and under budget.

. Coordinated the adoption of the SEI CMM program to establish process

improvement and establish documented software practices.

. Designed, developed and implemented accepted standards for software

quality assurance used with clients.

~ GAMBRO Healthcare - Renal Care / COBE Cardiovascular / Fisher Imaging ~

Additional Experience

Consultant Owner - TRE CONSULTING, Denver, CO - August, 1994 to April, 1996

Personal Financial Advisor - American Express Financial Advisors, Inc.,

Denver, CO - May, 1994 to May, 1995

Financial/Operations Manager - Edge Talent Management, Denver, CO - 1992 to

1994

Manager/Owner - Twin Peaks Travel, Longmont, CO - 1988 to 1991

Financial Researcher/Internal Auditor - Telautograph/OMNIFAX Corp., Los

Angeles, CA - 1987 to 1988

SYSTEM AND SOFTWARE EXPERIENCE

Platforms / Operating Systems

Windows (All VMware ESX 4.1 Oracle VirtualBox HP UNIX (HP-UX)

Versions)

DEC VAX (OpenVMS) IBM MVS/CICS DG UNIX SUN Solaris 2.5.1 /

2.6

DEC Alpha (OpenVMS) IBM RS/6000 (AiX) Alpha NT Novell 4.11

Software

MS Office Suite SQL / SQL Plus UNIX/Shell C, C++, C#

Programming

Visual Studio 05/08 Salesforce / Sugar Ruby WATiR Java

CRM

Ab Initio ETL Tool Mercury WinRunner Rational SQA Robot Accounting and

Automated Testing Automated Testing Financial Software

Tools Tools Systems

PVCS Visual Source Safe Perforce Seapine Suite - TTP

EDUCATION AND AFFILIATIONS

B.Sc., International Business / Finance - University of Colorado at Denver,

Magna Cum Laude

American Society for Quality - CSQE - Certified Software Quality Engineer

Software Quality Association in Denver (SQuAD) - Quality Assurance

Institute

Boy Scouts of America - Den Leader

Willing to Travel ** References Available Upon Request

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