SUMMARY

Highly skilled and motivated quality and business management professional

with an extensive electronic/electro-mechanical manufacturing and design

background. Proven leadership capabilities to develop and deploy strategic

business initiatives sharply focused on ensuring ongoing business success

and growth. Proven ability to maintain ISO 9001 and ISO 13485 quality

management systems that are fully aligned with dynamic business objectives

and strategies.

CORE COMPETENCIES

> Expert in ISO 9001:2008, ISO 13485:2003 and ISO 14971:2007; strong

working knowledge of FDA Part 820 QSR

> Strong leadership skills including capacity planning, resource

management, and employee performance assessment and development

> Exceptionally strong data analysis, root cause analysis and corrective

action skills

> Extensive ISO auditor and auditee experience; proven ability to

interface effectively with second and third party auditors

> Expert in problem-solving methodologies and tools (PDCA, Kaizen,

Pareto Principle, Ishikawa/fishbone, fault tree analysis, 5 Why's).

> Certified 8D Team Leader; trained Six Sigma Green Belt. Extensive

capabilities in MS Office program suite.

> ASQ Certified Quality Auditor - Obtained Certification June 2013

> Extensive knowledge of electronic, electro-mechanical and mechanical

design and manufacturing; over thirty years of experience in the

electronics industry

> Proficient in supplier quality management, including supplier quality

auditing

PROFESSIONAL EXPERIENCE

SPARTON MEDICAL SYSTEMS, Frederick, CO

June 2012 - Present

Senior Quality Engineer

Senior quality engineer for a contract manufacturer of medical and

commercial mechanical and electromechanical devices. Responsible for

ongoing quality support for sixteen manufacturing programs, as well as new

product introduction support for new business. Lead internal auditor and

recognized resident expert on ISO 13485:2003.

. Ongoing customer interface as assigned Quality Engineer for numerous

manufacturing programs; routinely process customer returns and

complaints including driving effective resolution through corrective

actions and process changes

. Recognized expertise in corrective actions; developed Root Cause

Analysis and Corrective Action Process training presentation; provided

this training to Sparton personnel as well as key suppliers

. Developed previously non-existent COQ metrics for Sparton Frederick

site

. Led Lean QMS Streamlining project that resulted in a 47% reduction in

Operational Procedures and significantly improved the alignment of

procedures and work instructions to ISO 13485 documentation

requirements

. Lead internal QMS auditor; responsible for creating and maintaining

annual internal audit schedule. Created new internal audit

certification and report documentation that significantly improved

audit report clarity and helped standardize reporting methodology

. Authored a comprehensive Internal Auditor training and certification

program; trained and certified nine new internal auditors. Created

and administered comprehensive ISO 13485 Requirements Overview

training document

. Completed Lean training and 48-hour Six Sigma Green Belt training

presented by Colorado Association for Manufacturing and Technology;

completed two highly successful green belt projects. Attained re-

certification as ASQ Certified Quality Auditor (June 2013); intend to

pursue ASQ Certified Quality Engineer certification as soon as

possible

. Completely thorough ISO 13485 - AS9100C QMS gap analysis in February

2013

. Promoted from Quality Engineer to Senior Quality Engineer in November

2012

ADVANCED ENERGY INDUSTRIES, Ft. Collins, CO

August 2010 - December 2011

Factory Quality Manager/SEBU Quality Assurance Manager

Factory Quality/Solar Energy Business Unit Quality Assurance Manager.

Managed the quality support processes and personnel for MRB, calibration,

product holds, ESD and 5S programs, Incoming Inspection and Product

Inspection (in-process and final) for products manufactured and serviced at

the Fort Collins site.

. Significantly improved/stabilized receiving inspection and

nonconforming material control (MRB) processes by establishing

personnel performance and material processing metrics

. Reduced receiving inspection backlog from 1.5 man-months to 1.0 man-

weeks

. Assisted with establishing and maintaining department operating

budgets Participated in Product Quality Team activities to help ensure

effectiveness; provided significant technical input to the team

TDP CORPORATION/VERGENT PRODUCTS, Loveland, CO

July 2008 - August 2010

Director of Quality

Member of Executive Management Team as Quality Director for an ISO

9001:2008 and ISO 13485:2003 certified contract design and manufacturer of

electronic and electro-mechanical products.

. Attained QMS certification to ISO 13485:2003 and ISO 9001:2008 in

October 2009

. Directed company's quality strategic planning efforts, and provided

significant contribution to corporate strategic planning

. Executed reassignment and restructuring of quality support

responsibilities that resulted in a 20% reduction in quality

department overhead

. Developed, documented, and implemented Risk Management program IAW ISO

14971:2007 requirements

PICOSECOND PULSE LABS, Boulder, CO

September 2004 - July 2008

Engineering Technician (PCB Design)

Sole responsibility for schematic capture and PCB design of high-speed (up

to 50GHz) circuits.

. Completed designs within demanding product development schedules;

received official recognition for this contribution

. Provided mechanical product and manufacturing tooling/fixture design

. Attained significant knowledge of high frequency circuit and PCB

designs

DENVER PLASTICS COLORADO, Hudson, CO

June 2000 - November 2003

ELDON JAMES CORPORATION, Loveland, CO

SUPREME CABLE TECHNOLOGY, INC., Thornton, CO

Quality Manager

Quality system and management for ISO 9002:1994, ISO 9000:2000 and NSF-

certified contract manufacturers of plastic injection molded parts and

electronic/electromechanical assemblies.

. ISO Management Representative and CQA (all companies)

. Lead Auditor for internal and supplier quality audits (all companies)

. Successfully developed and implemented an ISO 9000-compliant quality

system from the ground up; subsequently attained ISO certification

(Supreme Cable Technology)

SPECTRALINK CORPORATION

April 1999 - June 2000

Quality Engineer

Responsible for quality improvements on high-density surface mount

telecommunications products. Fulfilled key requirements for SpectraLinks'

attainment and retention of ISO 9000 Certification. Performed database

failure analysis, root cause investigation, and corrective action

implementation

UNITED STATES NAVY

Aviation Electronics Technician 2nd Class (AT2)

EDUCATION

US Navy Avionics - Advanced Electronics

AAS Classes - Polk Community College (Humanities, English, Algebra)

Ongoing professional development courses as previously referenced

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