Lemast Consulting

Matthew Taylor

6675 South Apache Drive
Littleton, Colorado 80120
303-829-4475
matt@lemastconsulting.com

Summary

• Quality Assurance and Operations Professional with a solid history of positive impact on product launch and reliability
• Demonstrated ability to enhance product quality and contribute directly to business growth, leveraging strategic focus and strengths in leadership, problem solving, research and analysis
• Optimistic and fair leader, adept at developing and empowering staff to succeed by providing tools and knowledge required to execute job functions

Professional Experience

2008–Present

Lemast Consulting, LLC.,

Littleton, Colorado

Principal

• Quality System development and implementation to 21CFR 820, for medical device manufacturer
• Validation and Verification planning for digital radiography software device, including Hazard Analysis
• Software test plan and execution to support release of medical device
• Preparation and submission of premarket clearance, 510(k) for new medical device

2008

Prototest,

Denver, Colorado

Consultant

• Managed and provided off-site Validation/Verification planning of a new medical device, under contract for Covidien

2001–2008

On Command Corporation,

Denver, Colorado

Vice President, Quality Assurance (2004–2008)

Director, Quality Assurance (2004)

Manager of Quality Assurance (2001–2004)

• Provided strategic planning and direction for Operations and Engineering Quality groups.
• Directed manufacturing, software and IT quality assurance professionals located in San Jose, California and Denver, Colorado. Managed $2.2 million budget and 21 employees
• Ensured products met or exceeded customer expectations
• • Developed and implemented New Product Development processes, Waterfall, Agile and Rational Unified Process (RUP) to support changing organizational structure
  • Led reliability initiatives that reduced server failure rate 74% over a three-year period, while increasing mean time to first failure on Video On Demand product 155%, over the same period
  • Planned, directed and championed a reliability improvement program that reduced client computer off-line rate 78%, by working with five independent operations groups (development engineering, sustaining engineering, video operations, quality assurance and manufacturing)
  • Developed and implemented software release criteria for software quality assurance team to reduce software delivery cycles times
  • Instituted system to collect and report field repair data to Operations Management and Engineering
  • Instituted receiving inspection controls that virtually eliminated UL variation notices

1998–2001

MedTrac Technologies, Incorporated,

Englewood, Colorado

Director of Operations, Quality Assurance & Regulatory Affairs

• Directed and oversaw all facets of operations, procurement, engineering, manufacturing, warehouse, and IT infrastructure. Maintained quality system and ensured full compliance with FDA requirements. Prepared all regulatory filings, monitored process validation, performed packaging testing, conducted complaint analysis and qualified vendors.
• • Ensured timely relocation of entire manufacturing and warehouse facility by planning and executing each step of the move from start to finish
  • Supported effective and efficient facility operations by developing and maintaining documentation for engineering drawings and procedures
  • Provided for data collection to support a significant clinical trial by a major manufacturer of handheld asthma inhalers, enabling release of customer’s new product with proven efficacy

1995–1998

La Bac Systems, Incorporated,

Lakewood, Colorado

Manager of Quality Assurance and Regulatory Affairs

• Developed, implemented and managed quality assurance systems to ensure compliance with FDA quality system requirements. Managed team of up to 11 in three departments: receiving, in-process and final inspection
• • Addressed and resolved all issues detailed in a prior FDA Notice of Adverse Findings, ensuring business continuity
  • Developed and implemented 21CFR820 compliant quality system
  • Facilitated successful integration of LaBac seating system to Everest Jennings wheelchair system after a merger of the two companies by integrating both quality systems. This was accomplished with several working sessions at facilities in Colorado and Canada

1994–1995

Medex, Inc.,

Broomfield, Colorado

Manager, Quality Control

• Manage Receiving, In-process, and Final Inspection departments for infusion pump manufacturer.
• • Assure timely release of product (both hardware and sterile product).
  • Prepared Inspection department for corporate relocation to Georgia (hardware) and Ohio (sterile disposables)

1991-1994

Fischer Imaging, Inc.,

Denver, Colorado

Senior Engineer, Quality Assurance

• Quality Engineering support for x-ray products
• • Inside liaison for company’s largest OEM customer
  • Led ISO 9001 certification effort, certification received ahead of schedule and under budget
  • Led development of service-to-failure reporting database
  • Software validation testing for computer tomography simulator

1984-1991

Mountain Medical Equipment,

Littleton, Colorado

Manager, QA & Regulatory Affairs

• Assure corporate compliance with Good Manufacturing Practices, 21CFR820
• • Developed and taught courses on Statistical Process Control (SPC)
  • Implemented SPC in inspection and engineering disciplines
  • Developed supplier audit process and performed supplier audits for key suppliers

1981–1984

Electromedics, Inc.,

Littleton, Colorado

Manager, Physiological Transducer Products

• Manage blood pressure transducer production line
• • Developed disposable fiber optic physiological transducer
  • Production engineering support for physiological pressure transducer
  • Production engineering support for sterile disposable products

1972–1981

Eaton Corporation, Electronic Instrumentation Division,

Marina Del Ray, California

Engineer, Physiological Transducer Products

• Engineering support for weldable strain gauge product line
• Sustaining engineering for physiological pressure transducer products
• • Led design improvements (manufacturability and reliability) for disposable fluid isolator for physiological transducer
  • Led design improvements (manufacturability and reliability) for pressure relief products for physiological transducer

1968–1971

US Army, United States Strike Command,

Mac Dill AFB, Tampa, Florida

Team Chief, Joint Airborne Communications Center/Command Post

• Operational deployment and maintenance of high mobility communications center
• • Deployed systems to over 10 international sites for communications purposes
  • Maintained high power (10,000 watt) HF transmitter/receiver systems
  • Maintained VHF and UHF systems, and associated peripherals
  • Held top secret security clearance with NATO, SEATO, and CENTO access

Education

BS, Organizational Management, Colorado Christian University; Lakewood, Colorado	1998
AA, Philosophy, Rio Hondo College; Whittier, California	1976

Professional Development

Lean Six Sigma Black Belt Training	SSD Global	2008
Dale Carnegie Training	Dale Carnegie, Colorado	2005
ASQ Certified Quality Manager Training	ASQ	2003
Reliasoft Reliability Block Simulator Training	Reliasoft	2003
Project Management	Harper and Associates	1994
Software Validation and Verification — Medical Devices	Varian Associates	1994
Software Testing and Development	Varian Associates	1992
ISO 9000 Lead Assessor Training	Stebbing & Partners, Inc.	1992
Demand Flow Training	JIT Institute of Technology	1987
Statistical Process Control Implementation and Training	ASQ, Education Training Institute	1985
Project and Program Management	California Institute of Technology	1981
Fixed Station Transmitter Repair	US Army Signal School	1969

Professional Certifications

Lean Six Sigma Black Belt	Certified	2008
ASQ Certified Manager of Quality/Organizational Excellence	Certified	2003
	Recertified	2005
	Recertified	2008
ASQ Certified Quality Engineer	Certified	1990
	Recertified	1993
	Recertified	1996
	Recertified	1999
	Recertified	2002
	Recertified	2005
	Recertified	2008

Professional Affiliations

Chair-Elect, Denver Section, American Society for Quality	2009–2010
Program Chair, Denver Section, American Society for Quality	2006–2010
Member, International Society for Process Improvement (ISPI)	2008–2010
Member, American Society for Quality (ASQ)	1985–2010