Engineer Quality

COLUMBUS CLARK COCKERHAM, JR

*** *** **** ***** ** ? Merry Hill, NC 27957

(H) 252/482-4522 (M) 919/219-1529 ********@*****.***

QUALITY ENGINEERING PROFESSIONAL SUMMARY

Proactive Senior Quality Engineer that is highly-organized, hands-on and

self-motivated. Credentials include a six-sigma black belt, being a

mechanical engineering patent holder and 8+-yrs medical device experience

in high volume ISO/cGMP injection molding environment. Accomplishments

cover: 1) leading 6-sigma process improvement projects 2) preparing

qualification protocols, tests and SOPs 3) completing CAPA projects and 4)

executing supplier audits.

CAREER ACHIEVEMENTS

QUALITY ENGINEERING

. Met protocol acceptance criteria and customer/regulatory

expectations by creating/ supervising the execution of protocols

used to validate over 100 production molding machines, mold tools

and instruments

. Assured that specified Customer Specs were met by completing

statistical analyses that predicted meeting specified AQL Levels

. Guaranteed a 0.025% DPMO Type II Error Spec was met by designing

tests, based on ANSI Z1.4, sampling plans, X? & R SPC Charts and

capability analyses

. Completed/supervised 30+ "% of tolerance" GR&R compliance by

executing crossed GR&R Studies of Lab instrumentation

. Enabled purchasing department to select vendor candidates by

completing vendor-screening audits and generating audit reports

. Identified source of product defect by identifying that IM-Resin

Supplier was not capable of producing a PP Resin that met the

company's Melt Flow Index Specification

PROCESS IMPROVEMENT

. Realized a 10% cycle time reduction, of injection-molding process,

without compromise to quality using a Fraction 25 - Resolution-V

DOE Design

. Saved 2-month project delay by chairing Process FMEA that eliminated

a process-fault

. Resolved a high profile customer complaint without added cost by

Leading a diverse 8-D method CAPA team

. Generated 33% savings over external validation quotations by

authoring/executing AQ, IQ, OQ and PQ protocols/test procedures for

custom instruments, automated production assembly lines and lab test

equipment

. Ensured that 21-CFR-820/ISO/customer specifications were met and

successfully defended a class II medical device final report in a

FDA Audit for a ISO/cGMP Injection molding plant.

. Saved $42,000 in sunk-direct-labor by developing 1st operational WI

to test/release incoming resin materials using a Fourier Transform

Infrared Platform

. Satisfied customer requirements by authoring WI that tested incoming

cannula with an INSTRON Force Gauging Instrument

MANAGEMENT

. Achieved customer/quality expectation by managing/mentoring

metrology and quality technicians for 3-yrs. that resulted in the

completion of over 100 validation projects Improved QA Inspector's

statistical and audit method comprehension/use using a mentoring

program

. Maintained schedule and resolved technical issues by leading

mechanical design/development-project of medium vacuum, low

temperature, chemical sterilizer (DV1000) from concept to production

. Managed QA Lab Personnel for 2-yrs to complete quality inspection

tasks that resulted in commercializing 2 new products and releasing

most products for shipment.

PROFESSIONAL EXPERIENCE

BERRY PLASTICS, INC - Easthamption, MA 5/03 - Present

Process Engineer

Led process mapping team that identified gaps between actual processes

and quality system documentation.

BERRY PLASTICS, INC - Ahoskie, NC 8/09 - 4/10

Continuous Improvement Engineer

Led cross functional 8D root cause and corrective action team that

determined how an injection molding defect was made and how the defect

left the plant. Developed work instruction to test WIP Compliance to

friction specifications and analyzed ability of WIP to meet expectation.

ALCAN Global Pharmaceutical Packaging, Inc - Youngsville, NC 9/05 - 12/08

Quality Engineer

Satisfied APQP requirements by creating a validation master plan for all

production and lab equipment that established tactical methods of

qualification identification, tracking and change control that met

internal and external expectations in an ISO/cGMP Blow Molding Plant.

MOEN, INC - New Bern, NC 1/04 - 9/05

Senior Quality Process Improvement Engineer

Improved 4-new-product-designs, during design review/risk assessments, by

ensuring Design-Control-Procedures/FMEA-Methods were followed. Analyzed

root cause of production process movement waste in Kaizen Event that

resulted in the reconfiguration of the Bidet Line's Workstations to meet

TAKT Time and a savings of $25,000/yr.

BESPAK, INC - Apex, NC 9/95 - 9/03

Senior Quality/Manufacturing Engineer

Wrote release PPAP documentation including quality plan,

verification/validation testing protocol/test instructions, as the

quality lead for a dry-powder-inhaler development project that met

internal design control procedures, external customer expectations and

regulatory requirements. Led cross functional team to resolve high

profile customer metrology complaint by re-measuring 196 lots of

delivered components and reconciling the remaining lots that satisfied

BESPAK/customer. Reduced labor by 75% and improved outgoing quality by

designing, building/validating custom instrument, using Pro-E, which

measured function of clinical DPI Device.

EDUCATION

BS-ME & BA-SOC; North Carolina State University; Raleigh, NC

MILITARY

US Army - 2-yrs

CERTIFICATIONS

6-? Black Belt Class and Black Belt Project Certifications from North

Carolina State University; Raleigh, NC (studied under Dr. Blanton Godfrey)

COLUMBUS CLARK COCKERHAM, JR

TECHNICAL SUMMARY

SOFTWARE SUMMARY

SOFTWARE

Application Skill Comment Last Used

Level1

MS Office 8 Current

MS Visio 8 Current

MS Project 8 Current

LabVIEW 5 2003

RS Logic 3 2002

Pro-Engineer 5 Intermediate Solid 2001

Modeler and

Assembler

AutoCAD 7 Advanced 2-D; Current

intermediate 3-D

FMEA-5 7 2001

MINITAB 8 Current

HARDWARE SUMMARY

Platform Skill Comment Last Used

Level1

PCs 7 Current

LabVIEW:

Signal Conditioning Modules 5 2001

16 bit Multifunction DAC 4 2001

Boards

RS 232 Interfaces 5 2003

AVITAR FTIR Instrument 7 2003

INSTRON Force Gage 6 2003

Instrument

A-B PLC 7 2001

NOTES: 1. Skill level range is 1 to 10 with 10 being the top end of

range

PATENTS & CERTIFICATES

Patents:

APPARATUS AND METHOD FOR WRAPPING AND SEALING CYLINDRICAL PACKAGES WITH

A STRETCH FILM MATERIAL; #4362001

ACCUMULATOR BASED LIQUID METERING SYSTEM AND METHOD; #5527507

A METHOD OF DECONTAMINATING FREEZE DRYERS; # 5837593

Certificates

LabVIEW Basics Certificate from MICROCRAFT, Corporation

Introduction to Pro-E Modeling Certificate from the RAND,

Corporation

Introduction to General Uncertainty Method from MITUTOYO

Corporation

A-B PLC Programming Certificate from BESPAK/ESC, Inc.

Introduction to Rapid Prototyping Certificate

Engineer In Training Certificate (EIT): #A-14683 from the

state of North Carolina

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