Quality Engineer

BARBARA KELLEY

________________________________________________________________________

Quality Engineer with significant quality assurance, materials testing, change

management, process improvement, order review, training, auditing, purchasing and

documentation expertise.

QUALIFICATIONS

OVERVIEW

More than 10 years diversified QA & engineering experience in medical technology,

contract assembly, chemical cleaning, computer & semiconductor manufacturing.

Experience includes the following:

- Certified Internal Auditor through RAB ISO 9000:2000 Auditor Transition training &

Malcolm Baldrige Auditor training with the 2000 Greater Austin Quality Award program

& the Austin Chamber of Commerce

- Creation & Management of internal audit programs, with training & certification of

internal auditors, including subcontractor audits

- Change Management, Project & Program Management with responsibility for managing

ECO processes

- Management of CARs and customer complaints, with 8D training & troubleshoot

process deficiencies with implementation of PAR & CAR solutions and leading

improvement teams

- Successful ISO 9000 certification experience & Certified Kaizen Team Leader & Care

Manager with successful completion of improvement projects

- Creation & management of multiple types of documentation, including: Engineering

Change Orders (ECOs), Standard Operating Procedures (SOPs), Work Instructions,

Assembly and Process Drawings, Bills of Materials (BOMs), travelers, internal audits,

corrective actions (CARs) and customers complaints, Discrepant Material Review

Reports (DMRs), Returned Material Authorizations (RMAs), Statistical Process Control

(SPC) Reports, Failure Mode Elements Analysis (FMEAs), First Article submissions to

customers, POs

- Certified "Train the Trainer" trainer with more than 10 years experience training adults

& formal classroom instruction experience teaching teens

- Ensure compliance with internal quality systems & external customer and regulatory

standards including ISO 9000, IPC, QS 9000, EIA, Jedec, OSHA, FDA, FCC, UL &

British Approval's Board of Telecommunications

- Experience with Start-up processes for manufacturing operations, including

implementation & management of Enterprise Resource Programs (ERP) automated

systems to support manufacturing processes

- Varied laboratory experience including, Biomedical, metallurgical, chemical, veterinary

& semiconductor inspection using microscopes & mechanical measurement tools

(Micrometers, CMM, height gages, Instron, standard microscopes & scanning electron

microscope), reading x-ray, performing nondestructive & destructive tests for inspection

- Adept in the use of software packages including: Excel, Word, Access, Acrobat, Quark,

Visio, Paint Shop, Photo Shop, L View, Power Point, Digital Cameras, Email, Html,

WWW & Internet, Norton Symantec, & various MRP/ERP programs

- Sourcing, Purchasing & Network support duties

- Class 100 Clean room experience.

EDUCATION

UNIVERSITY OF TEXAS AT AUSTIN, Bachelor of Science in Mechanical

Engineering, emphasis in Material Science (1991)

AUSTIN COMMUNITY COLLEGE, Associate of Science in Pre-Engineering (1988)

PROFESSIONAL HISTORY

ABBOTT SPINE – Through Oxford Global Resources – Consultant Quality Engineer/

Complaint Investigator

4/2008 through 12/2008

Conduct technical investigations & answer customer complaints for spinal implants in

FDA compliant environment. Wrote MDR submittals.

SILICON SERVICES CONSORTIUM – QA/QC Engineer

08/2006 until 10/2007

Manage flow on RF generators. Manage DMRs & resolve manufacturing repair issues.

Complaint resolution on parts RMAs. Complete Final QC inspections on refurbished C1

tools before final shipping. Assist with Design & Implementation of process

improvements. Introduce new elements of the Quality system as SSC was ready.

Sourcing parts & repairs. Purchasing & placing POs. Collections. Assist Marketing &

sales with sales of surplus parts. Was offered a Sales Job in SMT.

ONE SOURCE MANUFACTURING – Quality Engineer

07/2005 to 12/2005

Manage all Document Control functions, including ECOs, change management process

& procedural updates for contract manufacturer and machine shop. Manage

nonconforming materials, compile & report routine monthly metrics. Manage ISO &

Safety Team program. Support implementation of new ERP program. Prepare & submit

1st Article submissions to customers to facilitate implementation of new products. Create

& conduct process training classes. Optimize processes & projects as directed by the Vice

President of Quality and the President.

CHATLEFF CONTROLS through Hawkins Associates – Quality Technician

03/2005 to 07/2005

Complete projects as directed by Quality Manager & assist QC Supervisor/ISO

Coordinator with technical aspects of Quality Management system for manufacturer of

heating & cooling components. Projects include development of process FMEAs for

submittal to customer, development of ISO compliant audit program & establish internal

audits system, create new or edit existing procedures & work instructions to bring

documentation in compliance with ISO requirements. Assist QC Supervisor with design

& implement ISO compliant customer complaint process. Assist with preparations for

customer & ISO audits, including design and implementation of basic SPC program.

DEL VALLE HIGH SCHOOL – High School Science Teacher

08/2004 to 11/2004

Teach High School Integrated Chemistry & Physics, developed technical lesson plans,

conducted lectures and hands on laboratory experiments, and tutored students.

LUMINEX – Quality Associate

02/2004 to 08/2004

Maintain Monthly QA reports and MRB documentation for biomedical diagnostic

equipment manufacturer. Complete technical GMP, ISO and FDA compliant, final

product reviews & give shipping authorization for products awaiting shipment to

customer. Resolve production and paperwork issues in FDA regulated biomedical-

manufacturing operation. Achieve auditor status. Assist with customer complaints. Assist

with organizing Quality meetings and publish meeting minutes.

BOCEK Austin - Quality Engineer (QA Eng.)

02/2001 to 11/2002

Diversified Quality support for Chemical Cleaning facility. Manage CARs, customer

complaints, internal audit program, and calibration & facilitated the change management

process; troubleshoot processes and train personnel to increase efficiency, lead

improvement teams for Austin site. Develop & conduct various operator-training

programs. Publish routine Quality metrics and Warranty metrics. Lead ISO certification

at Austin site and assist in ISO Certifications for multiple sites. Implement & manage

SPC programs. Special projects from company President, Quality Managers &

Operations Managers, for proprietary industrial cleaning operations. Completed Kaizen

Leadership, 5S & RAB ISO 9000:2000 Transition Training. Specific achievements

include:

- Lead Kaizen improvement team which reduced major failure mode by more than 50%.

- Secured ISO 9002 certification for Austin site, without costly ISO Registrar pre-audits,

saving approximately $6000.

- Achieved Lead Auditor position, completing more than 80% of Internal Audits on

Austin site in 2001 & 2002, & certified internal auditors for Austin site.

SYNTEC - Program Manager, Lead Internal Auditor, Trainer, QA Eng. and Document

Control

01/99 to 01/2001

Responsible for change management process, ECOs & implementation of new processes

& products into the manufacturing stream. Program Management & Quality Engineering

related duties in support of contract assembly operations. Manage CARs, MRBs,

calibrations, & internal audit program. Coordinate & update policies, procedures,

instructions, process changes and training records. Write & conduct multiple training

programs. Certify employees in ISO 9000 Manufacturing, ESD protection, & Internal

Auditing requirements. Participate in 2000 Greater Austin Quality Award through Austin

Chamber of Commerce, earning a Baldrige Quality Auditing Certification. Responsible

for multiple other projects, as directed by Quality Director and Vice President of

Operations.

SURFACE MOUNT TAPING, Inc. – Internal Auditor and QA Eng.

02/1997 to 06/98

Responsible for maintaining Master Traveler manufacturing documentation for Tape &

Reel operations in an extremely dynamic, multi-customer environment. Responsible for

change management process, ECOs & implementation of new processes & products.

Responsibility started at the front end with order review & ended with answering

customer complaints. Review, implement, & train personnel in procedural changes.

Troubleshoot process deficiencies & implement process improvements. Specific

achievements included:

- Secured "Grandfather List" from largest customer, which allowed company to purge

stock on obsolete raw materials before ordering new materials. Estimated value of

savings $100,000.

- Completed overhaul of Master Traveler documentation resulting in simpler

documentation and improved quality.

- In an emergency situation wrote FMEAs for Austin Site in a week, keeping customer on

board.

- Brought material selection process under control, to meet the various customers' diverse

specification requirements.

APPLIED MATERIALS, in Austin, TX - QA Technician for Manpower

10/95 - 04/96

Inspected PVD machines. Collected quality data and assisted in building Pareto Charts.

Wrote Quality documentation that allowed Endura Mainframe Work center employees to

perform their own inspections. Completed Lean Mfg. Basics and Line Design class.

TADPOLE TECHNOLOGY, INC. Austin, TX - Manufacturing and Quality Coordinator

02/94 - 05/95

Manage & coordinate change management, ECO process, support manufacturing &

quality control activities at Austin facility for notebook computer manufacturer. Identify

& resolve quality & process problems. Coordinate & document changes on

manufacturing floor & within MRP system. Maintain & update part numbers, BOMs,

assembly drawings, & manufacturing records. Train assemblers in assembly procedures.

Develop & implement traceability systems. Specific actions taken & achievements

included:

- Assessed requirements to bring piece parts into conformance with various standards. In

emergencies purchased parts to ensure production schedules were met.

- Controlled U.S. software upgrade process. Developed process documentation in U.S.

The enhancement enabled company to follow the complex software upgrade process &

know which of the current multiple software versions was in effect.

BASTROP VET HOSPITAL, Bastrop, TX - Veterinary Technician

09/92 - 04/95

Observed large & small animals & made reports to vets. Medicated\treated animals as

directed. Assisted in surgeries. Maintained facilities. Worked medical emergencies.

ENCORE ORTHOPEDICS, Red Rock, TX - Associate Eng. & Production Coordinator

06/92 - 07/93

Direct production package staging & work order release for this start-up joint

replacement manufacturer. Assist in the design & implementation of automated

production control system. Continually engage in process refinement. Convert manual

production routings to computerized system in a FDA compliant environment. Specific

achievement included:

-Salvaged problematic shipments where traceability had been lost, saving an estimated >

$100,000.

CARBOMEDICS, INC., Austin, Texas - Quality Control Inspector

09/81 - 08/86

Performed mechanical inspections on heart valves, using: optical comparator,

micrometers, homemade gauges for dimensional inspections, microscopes to evaluate x-

rays & perform visual inspections on valves, and dye penetrant and destructive strength

testing. Final Inspections before shipment in FDA compliant environment.

References available on request.

201 W. Stassney #113B Austin TX 78745

512-***-**** email: ************@*****.***

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