Engineer Quality

KEITH W. CARROLL ASQ CQE, CQA

*** ****** ******,

Gibsonville, North Carolina 27249

Day Phone: (336) 495 - 9758

Eve Phone: (336) 449 - 5918

Email: abiq27@r.postjobfree.com

EMPLOYMENT OBJECTIVE

Quality professional is seeking to continue a career within administration

of quality disciplines, launching improvement initiatives and for

achievement of critical company goals.

SKILL SET

. Change Control Administration

. Risk Analysis Methodologies (xFMEA,

Fault Tree)

. Sampling Plans - Risk based and AQL based (ANSI/ASQ Z1.4, Z1.9 and

C=0)

. Process Validation Protocols (IQ,OQ,PQ), DOE and Cpk/Ppk Studies

. Test Method Validations, Gage R&R, Metrology

. CAPA, Failure Investigations, NCMR, MRB, Complaint Resolution

. Project Management (Global PM, APQP, PPAP)

. Compliance Auditing (Internal and Supply Base)

. Software: Microsoft Word, Excel, Access, PowerPoint, Visio,

Outlook, Lotus Notes

. Systems: JD Edwards, QAD, SAP, Documentum, LiveLink, TrackWise, Minitab,

Stat-Graphics, Quantum, DataMyte, Q&MIS, Agile

CAREER HISTORY

. 25+ years experience within manufacturing of Electronics, Plastics,

IVD Medical Devices and Pharmaceuticals

. Managerial function for direction of multi-site quality systems and

metrics reporting

. Quality Disciplines: Quality Engineering, Supplier Management,

Process Validations, Quality Assurance, QC Inspections, Compliance

Auditing, Documentation Control, Calibrations, Metrology and

Performance Metrics

. Direction of quality resources and personnel (24 departmental

members)

. Registration and maintenance of quality systems within a variety of

compliance and regulatory venues,

(FDA 21CFR820, -610/611, ISO13485, ISO9001, ISO14001, QS9000, MIL-Q-

9858A, and HACCP)

. QA Engineering liaison for technical transfer from design to

manufacturing

. Trainer/facilitator leading collaborative teams in continuous

improvement and Lean/Six Sigma initiatives

. ASQ Certified Quality Engineer, ASQ Certified Quality Auditor

EMPLOYMENT HISTORY

Sr. Quality Engineer

7/2008 to Present Date, Teleflex Medical - Asheboro, North Carolina

Class III Catheter based Therapeutic products and Surgical kits

Achievements

. Developed Process FMEA for critical product line

. Assisted in outbound transfers of product lines

. Quality lead for inbound transfer of multiple product lines from

sites undergoing closure

Quality Engineer

2/2006 - 7/2008, Catalent Pharma - Raleigh, North Carolina

Sterile technologies, Pharmaceutical and Medical Device Manufacturing

Achievements

. Development of key quality system elements (CAPA, Change Control

and Management Review)

. Assisted in corporate launch of site dashboard metrics and site to

site comparison

. Lean techniques for Micro-lab headcount for ability to incorporate

outsourced testing (90K annually)

Quality Manager / Quality Engineer

12/2004 - 2/2006, Moll Industries - Seagrove, North Carolina

Medical Device, Automotive and Specialty Plastics Injection Molding

Achievements

. Developed and assisted in implementation of real-time QC inspections for

reduction to COQ assessments, 33% reduction in production scrap, and

creation of a tail-gate sample program.

. Development of risk analysis procedures and associated improvement

methodologies for elimination of chronic product defects

Senior Quality Engineer

5/2002 - 12/2004, bioMerieux, Inc. - Durham, North Carolina

North American Headquarters for IVD Medical Device R&D and Manufacturing

Achievements

. R&D/Quality team member for new product line (glass to plastic

transitions)

. Development of supplier management rating and graphical status

reporting

Supplier Quality Engineer

5/2001 - 10/2001, EMC Corporation - Apex, North Carolina

Enterprise Storage Manufacturing

Achievements

. Kaizen blitz for supplier RMA turnaround (from15 to 3 days) of failure

analysis

Quality Engineer / Quality Manager

2/1998 - 5/2001, SCI Systems, Inc. - Graham, North Carolina

PCB Assembly, Controllers, Power Supplies and Computer Box-builds

Achievements

. Six Sigma project for increased (25%) ICT throughput and improved

first pass yields (97%)

. Project lead for scrap cost avoidance from 8% to 2% per sales dollars

. Implementation bar code Shop Floor Data Collection system for tracking

product location, status and defects

. Lead team for site certification of Alamance County's first company to

obtain ISO14001 Environmental standard

. Developed electronic system for documentation control (SOPs, WIs, Forms,

Control Plans) with connection to ISO elements

. Assisted in development of RMA repair center and shop floor databases for

tracking fabrication/defect tracking/repair/revision updates

Quality Engineer

8/1997 - 2/1998, Nypro Carolina - Burlington, North Carolina

Medical Device Plastics Injection Molding

Achievements

. Developed color-coded product lines for elimination of product mix-

ups from manufacturing to packaging

. Quality liaison for customer new product line performing capability

analysis and product qualification studies

Senior Quality Engineer

3/1997 - 8/1997, Micron Electronics CMS - Durham, North Carolina

Contract Manufacturing of high speed/ high volume computer memory modules

Achievements

. Development of manufacturing scrap tracking system resulting in a salvage

of $90,000 vendor assignable scrap

Corporate Member - TQM

2/1996 - 3/1997, LabCorp - Burlington, North Carolina

Medical Reference Laboratories

Achievements

. Team member in development of nation wide video based training for

improvement and cost reduction techniques

Product Assurance Engineer / Quality Manager

10/1985 - 10/1995, AT&T-Federal Systems Advanced Technologies -

Greensboro, North Carolina

Defense Contracts Telecommunications Manufacturing and Project Offices

Achievements

. Engineering achievement ($116,000 for cost reduction) for in-house cable

building processes versus purchased items

. Development of database of exemptions to military standards for assisting

manufacturing operations

. Team member in the development and maintenance of supplier rating system

and purchase order flow down requirements

. Supply base reductions and promotion of supply line partnerships for

factory's first preferred supplier having MRP stocking privileges

QA Supervisor / QC Analytical Chemist

5/1980 to 10/1985, P. Lorillard - Greensboro, North Carolina

High Speed / High Volume Manufacturing of Tobacco Products

Achievements

. Project leading to supply line requirements for uniform materials

in support of manufacturing

. Development of colorimetric techniques for uniform new product line

. Development of software programming for machine controlled

inspections

Chemical Reagents Manager

1/1979 - 5/1980, Granite Diagnostics - Burlington, North Carolina

Microbiological Media Manufacturing and Laboratory Components

Achievements

. Development of lyophilized product lines and supporting packaging

. Development of specialized quality control techniques for new

product lines

CERTIFICATIONS DEVELOPMENT

. Certified Quality Engineer (ASQ-CQE #46801)

. Certified Quality Auditor (ASQ-CQA #30562)

. ISO-9000 Lead Assessor (IQA Stebbing & Partners #1109)

. ISO-9000 Lead Auditor Examination (RAB Excel #1369)

. Six Sigma Green Belt (Cutler-Hammer)

. CPIM MRP/CRP (APICS)

. Global Project Management (AT&T)

. Process Quality Management and Improvement (AT&T)

. Six Sigma Green Belt (Cutler-Hammer)

. Lean Manufacturing Principles (NCSU)

. Lean Manufacturing and JIT Methods (AT&T)

. Effective Problem Solving and Root Cause Analysis (NCSU)

( Global Project Management (AT&T)

( Process Quality Management and Improvement (AT&T)

( Management Development Institute (UNC-CH)

. Total Quality Management - (George Washington University)

( Business Results from TQM (ASQ)

( Principles of Supplier Management (ASQ)

( Situational Leadership (Blanchard & Associates)

( Effective Negotiating (Karrass Seminars #8974)

( CPIM MRP/CRP (APICS)

EDUCATION REFERENCES

University of North Carolina, Greensboro, N.C. Professional and

character references

Bachelors, Double Major: Chemistry and Mathematics provided upon request.

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