Quality Assurance Medical Device

Frank Linton

*** ******** ***** ***** . *******-Salem, NC 27107 . Home 336-***-****

EXECUTIVE SUMMARY

A quality professional with experience in cleanroom, chemical processing

and portable energy device industries. A career spanning more than a

decade in industries supporting the medical device, semi-conductor, paint

and wood working manufacturers.

PROFESSIONAL HISTORY

Quality/Process Engineer (Contractor)

06/2007 - Current

Energizer Battery Company, Asheboro, NC (Aerotek Engineering)

Ensure product and process integrity for 9 Volt (522), N (E90), and 539

batteries. Participate in process improvement Kaizens. Interface with multi-

site product quality control systems, engineering, and manufacturing groups

to resolve process and product technical issues. Use statistical techniques

to analyze process capability of manufacturing operations. Suggest

processing and product construction changes, and solve both short- and long-

term problems. Develop and recommend cost reduction opportunities for 4A

lean manufacturing value stream. Give direction to laboratory and

manufacturing associates in order to achieve optimum product & process

efficiency.

Manager of Quality Assurance & Control

08/2006 - 01/2007

Akzo Nobel, High Point, NC

Manage and Coordinate testing activities of three Quality Control

Laboratories for Industrial Coatings Manufacturer; Responsible for

management and resolution of customer complaints; Assist sales group on

technical support visits; Responsible for the management of laboratory

equipment, personnel, and resources; Supervise staff of fourteen quality

personnel; Provide technical support for large technical sales force;

Recommend process improvement measures;

Supervise adjustment of product color and physical properties for top tier

customers; Collaborate with R&D to optimize quality control testing

procedures; Responsible for steering evolving quality management system.

Manager of Quality Assurance & Control

12/2001 - 8/2006

Jowat Corp., High Point, NC

Manage and Coordinate testing activities for Quality Laboratory of Adhesive

Manufacturer; ISO Management Representative for Jowat Corporation and Jowat

International; Implementation and registration to ISO9001:2000 Standards;

Responsible for Quality Management Systems for High Point, NC and Anaheim,

Ca facilities; Responsible for management and resolution of customer

complaints; Assist sales group on technical support visits; Responsible for

the management of laboratory equipment, personnel, and resources; Track and

monitor plant process efficiency; Recommend process improvement measures;

Maintain calibration system; Interface with Purchasing group to assure raw

material integrity and optimize supplier efficiency; Interface with

Materials Planning group to optimize use of raw materials and remix

consumption; Responsible for steering company process improvement teams:

targeted at on-time delivery/customer responsiveness & remix/scrap

reduction; Responsible for statistical analysis of product and process

variances; Monitor & measure contributing root causes of machine down-time;

Measure and track financial cost of returns, mixing errors, and rework;

Responsible for training and leading of company internal audit team;

Interface with customer service and sales groups to facilitate distribution

and sale of reclassified materials.

Quality Assurance Laboratory Manager

12/1998 - 12/2001

ITW Texwipe Company, LLC Kernersville, NC

Manage Quality Laboratory for cleanroom manufacturer serving medical device

and semi-conductor industries; Responsible for Kernersville, NC and Juarez,

Mexico laboratory budgets; Train laboratory and quality assurance

personnel; Implement various test methods for alcohol fill lines and fiber

analysis; Responsible for purchasing laboratory equipment for multiple

sites; Responsible for compliance of safety regulations; Develop product

control limits; Implement laboratory SPC; Responsible for analysis of

manufacturing process efficiency; Participate in the development of PVA

line and test methods

Senior ISO Facilitator for Kernerville, NC and Clearwater, FL Facilities

6/1996 - 12/1998

ITW Texwipe Company, LLC Kernersville, NC

Direct quality auditors and technicians for cleanroom manufacturer serving

medical device and semi-conductor industries; Write and review documents

for ISO 9002 compliance; Responsible for document issuance, control,

storage and maintenance; Write and verify specification and BOM

requirements; Participate as a member of the External Auditing Team; Team

leader for the Internal Auditing Team; Responsible for ISO 9000 training of

employees; Purchase and manage ISO documentation database; Advise quality

personnel for Philippine and Mexico manufacturing facilities

Document Controller

1/1996 - 6/1996

ITW Texwipe Company, LLC Kernersville, NC

Assist the Senior ISO Facilitator in the creation of the Document System;

Participate in the Product Data Management Team; Advise Customer Returns

Clerk in document issues; Work with suppliers to develop specifications and

incoming quality plans

Professional Courses & Seminars

NCA&T / ASQ Six Sigma Black Belt Certificate Program 9/2008-

7/2009

Adhesive and Sealant Applications 6/2005

Virginia Polytechnic Institute and State University

Satellite Campus (online program)

Six Sigma: Total Quality Applications 3/2005

Forsyth Technical Community College

Winston-Salem, NC

Supply Chain Management Applications 3/2005

Forsyth Technical Community College

Winston-Salem, NC

Six Sigma: Total Quality Applications 1/2005

Forsyth Technical Community College

Winston-Salem, NC

Supply Chain Management Fundamentals 1/2005

Forsyth Technical Community College

Winston-Salem, NC

ISO 9000:2000 Transition 4/2001-7/2001

North Carolina State University

Raleigh, NC

Introduction to Quality Engineering 11/2000

North Carolina State University

Raleigh, NC

BSI ISO 2000 Conference 8/1997

Binghampton, NY

Professional Courses & Seminars continued

Advanced Topics in Statistical Process Control

11/1997

University of Tennessee

Knoxville, TN

ASQ Record Control and Documentation Conference 3/1997

Charlotte, NC

RV Armstrong Internal Auditing Seminar 8/1995

Greensboro, NC

Oliver Wight Materials Requirement Planning 3/1995

Kernersville, NC

Professional Affiliations

American Chemical Society (ACS) 2000-2002

American Society for Quality (ASQ) 1995-

Present

EDUCATION

Winston-Salem State University

Winston-Salem, NC

Bachelor of Science in Chemistry

Honors: Cum Laude

REFERENCES

Available upon request

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