This document provides a summary of Bruce Pfeffer's qualifications and experience. He has over 30 years of experience in quality engineering, metallurgy, and manufacturing across multiple industries including medical devices, aerospace, and automotive. Pfeffer holds certifications in quality engineering and auditing and is a Six Sigma Green Belt. He has a track record of improving quality, reducing costs, and ensuring regulatory compliance at various companies.

1. BRUCE PFEFFER, CQE, CQA
Fort Worth, TX 76179
321-946-7956 bruce@labeyes.com
www.linkedin.com/in/pfefferbruce
SUMMARY
An accomplished engineering professional with extensive experience in medical device,
aerospace and automotive manufacturing industries. Expertise in Quality Engineering and
Metallurgy. Excellent interpersonal skills in exceeding the expectations of internal and external
customers, including data analysis and presentation of opportunities for process and product
improvement. Exceptional skills:
• CAPA and root cause analysis • Lean manufacturing
• CQE, CQA and Six Sigma Green Belt • Material testing and inspection
• Gaging & Measurement System Analysis
• AS9100 &ISO9001 QMS Documentation
• Team building
PROFESSIONAL EXPERIENCE
DIAMONDBACK INDUSTRIES, Crowley, TX November 2014-Present
Measurement Systems Analyst
• Key contributor to the AS9100 Certification initiative, writing SOP’s and performing gap analyses.
Lead analyst for validation of gaging and measurement methods for complex machined parts for oil
exploration tooling. Hands-on involvement in all types of gaging and part measuring processes,
including operator training.
EDWARDS LIFESCIENCES, Draper, UT September-October 2014
Contract Quality Engineer
• Review of Complaint Files to assure that complaint investigations comply with FDA requirements.
• Review of Inspection Gauge OOT events to determine the Root Cause and need for CAPA follow
up.
ALCON LABORATORIES, Fort Worth, TX & Orlando, FL 2006 – 2014
Senior Complaint Analyst - Medical Safety
• Career progression in Medical Device Quality Assurance including roles of Complaint Monitor,
Safety Monitor, and Investigator.
• Developed complete skill set for complaint handling, from customer contact through file closure.
Responsible for reporting decisions, follow up, technical investigation and Corrective Actions.
• Documented the Voice of the Customer for FDA Compliant Post Market Surveillance activities, and
developed and presented complaint trend analyses for adverse events and reportable malfunctions.
• Performed Quality Engineering role in product investigations for a variety of medical device product
lines, including refractive and surgical instrument systems.
• Provided technical investigations for customer returns and inspection rejects, including Root Cause,
CAPA, and Risk Management impact.
SPARTON MEDICAL SYSTEMS, DeLeon Springs, FL 2005 – 2006
Medical Cell Manager
• Production team leader for engineers and assembly personnel for low volume-high mix
electromechanical medical devices. Responsibilities included Process Validation,
Inspection and Test, Device Records, Vendor Quality, and New Product Development.

2. • Quickly achieved goals for Rework Reduction and Cycle Time Reduction: Improved
productivity by 18% within 2 months.
• Captured “hidden factory” costs and enabled quality improvements using standard rework
instruction procedures and expedited disposition of non-conforming product.
• Improved on time delivery from 70% to 100%, by identifying and resolving critical lead time
issues using lean concepts, and improved quality, labor efficiency and cycle times.
• Implemented self-directed work team concept, dramatically improved New Product
Introduction, providing production operator participation in the engineering build phase.
EATON CORP, Engine Air Management Operations, Roxboro, NC 2003 – 2005
Inspection Dept. Manager / Plant Metallurgist
• Exceeded assigned goals in team leadership role for inspection and gauging activities in the
manufacture, assembly and test of automotive valve components for major automotive
manufacturers. Responsibilities included Receiving Inspection, Process Auditing, Gauge
R&R, Changeover Validation, Quality Planning, Training, and Lean Manufacturing initiatives.
• Facilitator for the “Barriers to Quality” program.
• Improved quality assurance inspection efficiency 25% using Kaizen and Value Stream
Mapping. The Inspection Dept. was the only department able to accommodate a 25%
increase in business without an increase in head count.
TECSTAR, INC. Durham, NC 2000 – 2002
Quality Assurance Engineer
• Led ISO Auditing, CAPA, SQA, Operator Qualification, SOP Writing, Demand Flow
Assembly and Test for Quality Engineering aspects of Aerospace component manufacture.
• Improved customer satisfaction to an acceptance rate of 98%, achieving the Gold Supplier
rating from Honeywell Aerospace.
• Eliminated compliance gaps with Boeing and Honeywell, and increased customer
confidence through responsiveness and quality focus.
• Served as the Lead ISO 9000 Internal Auditor.
• Reduced supplier non-conforming materials by 50%, identified CTQ (Critical to Quality)
issues and motivated suppliers to improve their processes.
• Facilitated multi-discipline process improvement teams that reduced costs by $175,000
annually, with improved product safety and reliability.
BLACK & DECKER, Fayetteville, NC 1999 – 2000
Process Quality Lab, Heat Treat Supervisor and Plant Metallurgist
• Led Process Inspection quality team in ISO Auditing, Lean Manufacturing, and Six Sigma
Projects.
• Reduced component warranty costs by $250,000, and streamlined acceptance testing for
internally produced and vended components using Six Sigma techniques, as leader of the
Heat Treat team.
HOWMEDICA ORTHOPEDICS, DIVISION OF PFIZER, Rutherford, NJ 1984 – 1999
Senior Quality Engineer-Operations Quality & Metallurgical Engineering Manager
• Activities included Design Review, Process Validation, CAPA, Route Cause, New Process
and Product Development, Quality Planning, Materials Lab Management.
EDUCATION
Bachelor of Science (BS), Mechanical Engineering, Metallurgy
Stevens Institute of Technology, Hoboken, NJ
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3. CERTIFICATIONS
ASQ Certified Quality Engineer, Certified Quality Auditor
Six Sigma Green Belt (Black & Decker Black Belt Program)
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