Engineer Quality

Lisa D. Greene

**** ***** ***** **.

Springboro, Ohio 45066

abmqe4@r.postjobfree.com

Home: 937-***-**** Cell: 937-***-****

SUMMARY

Senior Quality Engineer with over 19 years in the manufacturing industry

including 10 years experience in developing elements of diverse quality

systems. An extensive background in implementing Quality Management

Systems. Global experience including expatriate experience in Budapest,

Hungary as a Quality Engineer. Strengths in quality system audits, voice

of the customer, root cause analysis, and building relationships with

suppliers and/or customers. Key skills include:

Internal Auditing Corrective and Preventive Action

Lean Manufacturing Advanced Product Quality Planning

Team Oriented Problem Solving (8D) Production Part Approval Process

TS 16949 /TS 13485/ ISO 14000 Failure Mode Effects Analysis

Statistical Process Control Control Plan Methodology

PROFESSIONAL EXPERIENCE

Evenflo Company, Inc (Miamisburg, Ohio) 2008 - 2010

Corporate Quality Engineer

Managed suppliers of class I medical devices produced in Mexico and China.

Assured adherence to FDA regulations per CFR Title 21 with regularly

scheduled quality audits. Performed internal auditing of the Evenflo

quality system per TS 13485 - Medical Device requirements. Worked with

suppliers in the development of Product Integrity Work Books (PIWB) for

product qualification. Developed Corrective Action and Preventive Actions

(CAPA) for internal quality issues. Approved supplier Device History

Records. Created packaging and literature specifications.

. Identified a cost savings of $30,000 with the development of a new

packaging configuration for medical devices distributed to various

European customers.

. Supported unprompted FDA audit which resulted in no key findings.

. Championed a CAPA that lead to the resolution for 20,000+ medical device

units that did not function properly with batteries.

Faurecia Exhaust Systems (Franklin, Ohio) 2005 - 2008

Program Quality Engineer

Prepared qualification documentation for "Big Three" automakers utilizing

the Production Parts Approval Process (PPAP). Developed corrective action

responses for customer complaints utilizing global 8D format. Implemented

methods and procedures for disposition of discrepant materials. Developed

Poka-Yoke techniques for in-line quality inspections. Provided support for

the Faurecia Excellence System (FES). Implemented Faurecia's Seven Quality

Basics for new product launches: OK first piece, Poka-yoke, Quality wall,

Red bins, Rework under control and Self inspection.

. Developed positive working relationship with The Big Three customers

which streamlined the production parts approval process.

Federal Mogul (Trotwood, Ohio) 2002 - 2005

Senior Quality Engineer / EHS Coordinator

Responsible for the implementation of a Quality Management System (QMS) in

the company as well as for the maintenance of the QMS. Lead Failure Modes

& Effects Analysis (FMEA) development for new and released products.

Initiated corrective and preventive action activities. Supervised quality

technicians and quality inspectors. Implemented and coordinated safety

programs to prevent or correct unsafe environmental working conditions.

Coordinated with outside organizations, such as the local fire department

and the Occupational Health and Safety Administration (OSHA); for the

design and installation of safety devices on machinery or clothing.

Investigated causes of industrial accidents to prevent further incidents.

Scheduled annual tests to ascertain air quality and noise levels.

Coordinated the training of workers on safety procedures using safety

equipment, devices, and clothing.

. Implemented and passed TS 16949 Audit in 6 months, 1 year ahead of

schedule

. Lead team to acquire Ford's Q1 Preferred Supplier Status within 1 year

. Governed two years of successful Quality Surveillance audits with zero

findings.

Delphi Corporation / General Motors Corporation 1989 - 2002

(Delphi Automotives was spun-off from General Motors, becoming an

independent publicly traded company, May 1999)

PPAP Coordinator (Moraine, Ohio) 2001-2002

Coordinated activities with Supplier Development and Quality Engineers for

accurate and on-time submission of product qualification documentation.

. Reduced PPAP non-conformances by 75% in 6 months by instituting a

computerized tracking system and the implementation of formal PPAP

planning and review sessions.

. Increased on-time PPAP completion by 32% in 6 months.

Quality Engineer (Balassagyarmat, Hungary) 2000-2001

Expatriate assignment as a quality engineer for Delphi's greenfield project

to launch a quality system for the new overseas manufacturer of air-

conditioning compressors.

. In 1 year developed and implemented Documentation and Auditing System for

TS 16949.

. Helped to developed bi-lingual Quality Manual in compliance to TS 16949

requirements.

Area Industrial Engineer Level V and VI (Moraine, Ohio) 1989-2000

Maintained manpower plans, labor standards, machine uptime, capacity, lead-

time and labor estimates for various production departments. Provided

support for the implementation of the Delphi Manufacturing System (DMS).

Supported central industrial engineering activities by providing planning,

forecasting, and performance data for plant and divisional use and prepared

workforce

. Performed 48 internal quality audits in 3 years as Lead Quality Auditor

for QS 9000

. Trained 40 Salary and hourly employees in 1 month to the basic

requirement of QS 9000 in preparation of periodic Surveillance Audits

EDUCATION

University of Dayton (Dayton, Ohio)

Master of Business Administration

University of Dayton (Dayton, Ohio)

Bachelors of Science in Industrial Engineering Technology

PROFESSIONAL DEVELOPMENT

ISO 9000 Certification

TS 16949 Internal Auditor Certification

Six Sigma Green Belt Training

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