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Quality Engineer Training

Chelmsford, MA
December 16, 2019

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Edmund Foley

** ******** ****** § Chelmsford, MA 01824

978-***-**** §


Quality /Advanced Manufacturing Engineering /Lean Sigma Black Belt / Project Management / Manufacturing Engineering / Logistics

Results-driven manufacturing professional with a reputation for meeting the most challenging organizational goals and objectives. Experienced in training, developing and leading highly motivated, winning teams. Astute in identifying areas in need of improvement with the vision to develop and implement successful action plans. Excellent analytical skills with ability to diagnose and solve processing problems. Additional strengths:

Quality & Performance Improvement

Technology & Engineering

Inventory / Materials Management

Production Scheduling

Strategic Planning

Sound Decision-Making

Computer proficiency includes MS Word; Outlook; Excel; Visio; Project. Also Minitab and Design-Expert


Becton Dickinson

Senior Quality Engineer

(07/17 to Date) Perform quality functions and Six Sigma training at the Andover facility for BD Andover and their suppliers. Some of the tools used are

Design controls

oDesign Failure Mode Effects Analysis ADFMEA

oProcess Failure Mode Effects Analysis PFMEA

oQuality Function Deployment, (QFD)

Measurement Systems Analysis

oSample creation and selection

oAnalysis and optimization

oPre-Gage R&R Simulation to improve 1st pass success rate.

oNested Gage Studies

oAttribute Agreement Analysis

Process Validation internally and with suppliers

oInstallation Qualification

oProcess Characterization

oOperational Qualification

oPerformance Qualification

Create inspection instructions

Gage Linearity and Bias Studies

Regression studies between gage systems

Equivalency studies between organizations

Assist Development team with

oHypothesis Testing

oCreation and Analysis or Design of Experiment

Create and present training modules for all manner of Lean and Six Sigma training as well as training for process validation, and process improvement hypothesis testing

Data Analysis

oDistribution Analysis

o Non-normal data

oSample size selection

oStatistical process control techniques

FDA 13485 2016 trained (Stat-O-Matrix)

Edmund Foley Page 2


Lean Sigma Master Blackbelt (09/15 to 01/17) Provide Lean and Six Sigma training globally for SN. Create training modules for all manner of Lean and Six Sigma training as well as training for process validation, and process improvement.

Design and implement kaizen events for decreasing lead time and yield improvement throughout Smith-Nephew globally and with SN suppliers

Identify new measuring equipment, and determine efficacy for new measurement systems.

Coordinate between suppliers and Smith-Nephew with regard to measurement discrepancies, comparisons between gauges, and process improvement with SN suppliers.

Create and deliver training modules in

oLean Sigma Greenbelt

oLeans Sigma Blackbelt

oMeasurement Systems Analysis

oDesign of experiment

oHypothesis testing

oStatistical process control

oProcess capability analysis

oBrainstorming methodologies

oMinitab for engineers

Principal Quality Engineer (06/13 to 09/15), Report directly to the Mansfield plant manager resolve specific quality challenges internally and externally, and to train and mentor Mansfield personnel on

Process validation

Problem solving methodologies

oImplemented 8D problem solving methodology training plant wide

Measurement Systems Analysis

oImplemented training internally and externally

Minitab Software

Hypothesis testing

oImplementing training plant wide Mansfield facility

Dealing with non-normal distributions

oEstablish company guidelines

Capability Analysis

Designed experiments

Mentor Engineers on

Designed experiments


oCentral composite designs

DMAIC problem solving techniques

Edmund Foley Page 3


Supplier Development Engineer (10/11 to 06/13), Work with Smith-Nephew suppliers to implement cost reductions and quality improvement projects via Lean and Six Sigma methods. This was accomplished thru

Week long lean manufacturing Kaizen events

oValue Stream mapping

oQuick changeover events

oDesigning Scheduling Matrices

oFinished good kanban sizing

On-site quality kaizen events such as

oGage R&R training

oProcess mapping

oCause and effect diagrams


Medtronic Inc., Danvers, MA 2000 – Sept 2011

Product Transfer Team (11/09 to present), Transfer the manufacturing of multiple products from between worldwide facilities.

Cross functional multi-site teams

Risk analysis and mitigation


Process validation

oProcess characterization

oOperational qualification

oPerformance qualification

Tolerance stack up analysis

Measurement Systems Analysis

Process improvement yield improvement, variation reduction process and tooling optimization

Created and present cross-functional training modules for engineers in the extrusion process and extrusion process validation. Training is designed to train non-plastic engineers, (ME, EE) to assist in the validation of extrusion processes

Provide Lean Sigma Black Belt training and mentoring for Lean manufacturing and Six Sigma projects for Green belts and Green belt candidates

Created standardized methodology for tooling selection in the Danvers facility

New product development

oDevelop multi-lumen tooling and processes


oDevelop new process for engineering resins such as Ultem, HMWHDPE, Pellethane, Pebax,

Lean Sigma Black Belt (6/07 – 11/09), for major worldwide developer and provider of medical equipment and technologies.

Apply Six Sigma strategies to ensure sustained maximum operational efficiency by initiating and leading Lean Manufacturing and Six Sigma projects. Focus is on Lean manufacturing initiatives, House of Quality (DFLM) and Six Sigma projects for business functions.

Delivered process improvements resulting in strong and sustainable financial gains, saving nearly $1 million in FY09.

Provide direction and training to engineers on use of Lean Sigma tools and statistical techniques.

Train Green Belts at Danvers location.

Train SPC, DOE, Minitab, Statistical methods for engineers

Edmund Foley Page 4

Manufacturing Engineer, 6/04 – 6/07

Management and engineering responsibility for production of various extrusion and molding processes.

Created yield improvements; designed experimentation, prototyping and implementation of new products.

Determined specifications; conducted feasibility, process validation studies and trials for new process introduction.

Assumed additional supervisory responsibilities during extrusion processes, in addition to engineering role.

Insert injection molding cell engineering, implementation, and personnel management

Senior Extrusion Technician 2000 to 6/04

Oversaw complete processing of all free extruded tubes, to include process troubleshooting and review of lot qualifications.

Established tooling, process conditions and designed processing research experiments for new product development.

Streamlined processes through effective interface with TPM, Lean Manufacturing, Constraint Management and SPC Techniques.

C.R. Bard, Billerica, MA

Senior Engineering Technician, R&D

Supported extrusion R&D department through processing of polymers. Recorded and submitted detailed records of test results.

Methods included free and multi-lumen extrusion; over-jacketing; metering pump extrusion; co-extrusion; pulse tubing.

Materials processed included PET, Polyurethane, HDPE, HMWHDPE, PBT, PEI, PEEK and more.


M.B.A., Business Administration, Endicott College, Beverly, MA – 2008

B.S., Business Administration, Endicott College – 2006

Certificate in Plastics Technology, University of Massachusetts at Lowell - 1998

Continuing Professional Education & Certifications:

Lean Sigma Black Belt Certification (Medtronic) 2008

Six Sigma Black Belt / Green Belt Training, Medtronic

Design of Experiment Training, Medtronic

Minitab Training, Medtronic

Project Management Training, Worcester Polytechnic Institute (WPI), Worcester, MA – 2005

Leadership Training, WPI

ISO 13485 2016 Lead Audit training Oriel Stat A Matrix

References furnished upon request

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