Quality Supply Chain

CAROL A. WESTMORELAND, ASQ CQA

Lebanon, TN *****

phone: 615-***-****

email: *******@*********.***

Skills:

. Quality Analysis- ASQ Certified Quality Auditor, Internal/Lead

Auditor - ISO 9000, ISO 13485, ISO 14000, ISO 20000, SOX, QS 9000, AS

9000, TS 16949, GMP, FDA regulations (21 CFR Part 110, 210, 211, 808,

812, 820), USDA, UL, CSA, CE, ANSI, ASME, HACCP, USDA, TSA

Regulations, Capability Maturity Model Integration (CMMI) Development

v 1.2, CMMI for Service Organizations v 1.2, HIPAA training, TQM

(Total Quality Management), Sig Sigma, Lean manufacturing, Kaizen,

Corrective Action plans, Preventive Action plans, Root Cause Analysis

and Investigation, 8D Corrective action, 8D problem solving and

trouble shooting, 5 Why problem solving, Measurement and testing

verification and validation, 5S, ORT(Ongoing Reliability Testing),

APQP (Advanced Product Quality Planning) documentation, PPAP

(Production Part Approval Process) documentation, blueprint reading

and GD&T, Inspector, Technician, SPC, Cpk, Capacity planning,

. Management/Supervision- Reporting, process improvements, logistics,

purchasing, supply chain management, capacity planning, buying,

auditing, analysis, action plans, technical writing, inventory

control, operations, production, QMS representative, safety, budgetary

planning, office/accounting management, change & risk management,

. IT - Hardware/Software troubleshooting, web design (page/site),

software testing, Healthcare Information Management Systems - HIPAA

Training

. Administrative/Clerical - accounting, payroll, medical billing,

coding and reimbursement, medical records auditing, word processing,

database design, technical writing, purchasing, create presentations,

spreadsheets, charts and reports

. Software - Microsoft Office Suite (Word, Excel, Powerpoint, Access,

Outlook), Microsoft SharePoint, Microsoft Live, Microsoft Project,

Microsoft Front page, Macromedia (Dreamweaver, Fireworks, Home site,

Flash), HP Quality Center, HP Quick Test Professional, PowerWay

(DM9000), Master Control, isoTracker, Documentum, Q-Pulse,

Brainkeeper, WinSPC, TQS-9000 (8D CA), MCATT, Ingenium training, Auto

CAD, QI macros (Excel SPC), Minitab (SPC), GagePro, Medisoft for

Medical billing and coding, SAP/ERP/MRP, AS400 accounting and

purchasing

Professional Experience:

Contract Assignment

ACS Healthcare Solutions / Internal Data Resources Process Quality

Assurance Analysis

June 2008 - November 2008

. Responsible for the development and execution of process and work

product quality reviews to comply with Capability Maturity Model

Integration (CMMI) Development v 1.2, CMMI for Service Organizations v

1.2, ISO20000 and ISO9001:2000,

. Published findings in the quality review report and collected metrics

based on findings,

. Develops corrective action plans (CAP), preventative action plans

(PAP) based on quality review findings, Conducted root cause analysis

and investigation,

. Change Management conducting process reviews to identify process

improvement opportunities,

. Monitored implementation of CAP/PAP and provided weekly status reports

on progress against CAP/PAP,

. Executed process improvement initiatives employing process improvement

methodologies and best practices,

. Provided support to complete quality reviews of deliverables prior to

submission to the client,

. Performed Document QA duties such as the editing, proofreading and

formatting of documentation,

. Conducted technical writing of procedures, manuals and process

instructions.

Gateway Pro Partners, LLC Quality Engineer /

Supervisor / Assistant Quality Manager

April 2007 - May 2008

. Acting quality manager,

. Supervised 12 quality auditors, 2 (ORT) on-going reliability testers,

2 engineers, 1 technician

. Coordinator for ISO9001 implementation, served as Lead auditor

(ISO9001, GMP, FDA, UL, OSHA, TOSHA),

. Develops 8D corrective action plans (CAP), preventative action plans

(PAP) based on quality review findings, Conducted root cause analysis

and investigation,

. Coordinated safety programs, training, investigations, inspections and

audits, tool calibrations, Kaizen projects, for new product launch,

first article inspection auditing, Change Management- process,

product, systems and document control,

. Quality leader for supply chain management, supplier process

improvement, material/parts requirements, deviations and Capacity

Planning,

. Conducted 8D problem solving, troubleshooting techniques, time

management studies for production and quality activities,

. Conducted technical writing of procedures, manuals and process

instruction.

Contract Assignment

Federal-Mogul / Kelly Automotive Services Quality Engineer

February 2007 - March 2007

. Internal auditor for ISO9001, ISO14001, & TS16949 standards,

. Developed APQP / PPAP packets for new customer product and team member

for new product launch,

. Conducted reliability testing, 8D problem solving, troubleshooting

techniques, blue print reading and GD&T,

. Develops corrective action plans (CAP), preventative action plans

(PAP) based on quality review findings, conducted root cause analysis

and investigation,

. Conducted technical writing of procedures, manuals and process

instructions.

Smiths Detection Quality Coordinator

February 2005 - December 2006

. Served as ISO 9001 Quality Management Systems representative

conducting Management reviews

. Served as Lead Auditor, (ISO9001, ISO14001, ISO13485, GMP, FDA,

USDA, HACCP, UL, OSHA, TOSHA, EPA),

. Conducted Change Management- process, product, systems and

documentation

. Coordinated safety programs, training, investigations, inspections and

audits, document control, tool calibrations,

. Served as ISO, quality and safety trainer,

. Quality liaison for supply chain management, supplier process

improvement, material/parts requirements, deviations (assessments,

evaluations, audits, point of contact), and Capacity Planning

. Conducted material audits and inspections, blue print reading and

GD&T,

. Develops corrective action plans (CAP), preventative action plans

(PAP) based on quality review findings, conducted root cause analysis

and investigation,

. Conducted technical writing of procedures, manuals and process

instructions.

Dell Inc Quality Compliance

Specialist / QA Engineer / Analyst

June 2000 - February 2005

. Served as ISO9001 / ISO14001 Document Control Coordinator, managing

and maintaining document control system to comply with ISO9001 and

ISO14001 standards,

. Served as Lead Auditor (ISO9001, ISO14001, GMP, FDA, USDA, HACCP, UL,

CCE, CA, OSHA, TOSHA, EPA),

. Conducted Change Management- process, product, systems and

documentation,

. Web Site administrator for all QMS/EMS documentation and web pages,

. Managed MCATT (Manufacturing Corrective Action Tracking Tool),

. Develops corrective action plans (CAP), preventative action plans

(PAP) based on quality review findings, conducted root cause analysis

and investigation

. Quality liaison with NPI engineering of new product launches,

blueprint reading, PPAP documentation and improvements,

. Conducted safety investigations, inspections and audits,

. Conducted Kaizen projects / Lean Manufacturing / Six sigma projects,

. Conducted technical writing of procedures, manuals and process

instructions.

Wright Industries, Inc / Manpower Staffing Services Quality

Specialist / Document Coordinator

February 1997 - June 2000

. Controlled ISO9000, QS9000, AS9100 Quality Systems,

. Administrator of PowerWay (DM9000)and Ingenium training software,

. Served as Internal and Lead auditor for ISO9001, QS9001, AS9001, GMP,

FDA, USDA, UL regulatory, ANSI and ASME

. Served as Change Management - process, product, systems and

documentation

. Coordinated tool calibrations and recorded results using Progage

tracking tool,

. Coordinated safety programs, training, investigations, inspections and

audits,

. Quality liaison with Purchasing department on supply chain management, supplier process improvement, material/parts requirements and

deviations (assessments, evaluations, audits, point of contact) and

Capacity Planning

. Created APQP documentation packets and PPAP documentation,

. Conducted blue print reading, GD&T, material inspections, first

article inspection auditing,

. Develops corrective action plans (CAP), preventative action plans

(PAP) based on quality review findings, conducted root cause analysis

and investigation,

. Technical writing of procedures, manuals and process instructions.

Briskin Manufacturing Co., Production Control /

Purchasing

November 1995 - February 1997

. Served as Production Control - planner/scheduler,

. Buyer of all raw materials, components, supplies, equipment and

Inventory control coordinator,

. Customer account representative, supply chain management, accounts

payable and accounts receivable

. ISO / QS9001 internal auditor,

. Coordinated safety programs, training, investigations, inspections and

audits,

. Develops corrective action plans (CAP), preventative action plans

(PAP) based on quality review findings, conducted root cause analysis

and investigation,

. Conducted technical writing of procedures, manuals and process

instructions.

Contract Assignments - Administrative Assistant Positions

August 1990 -- November 1995

The Holland Group Human Resources

Placement Coordinator

. Coordinated selection process of applicants, interviewing,

placement, and orientation,

. Served as Assistant Office Manager, processing payroll, purchasing,

accounts payable and accounts receivable.

The ABC Group/ Olsten Temporary Services Accounting

Coordinator

. Accounts payable and accounts receivable coordinator, processed 300-

500 invoices weekly using AS400,

. Assisted Controller and Purchasing coordinator with appointed duties,

McFarland Hospital/ Olsten Temporary Services

Administrative Assistant

. Conducted Joint Commission on Accreditation of Healthcare

Organizations (JCAHO) preparations,

. Streamlined documentation process, converted manual procedure manuals

to digital format,

. Updating procedure manuals documentation utilizing technical writing

skills,

. Audited medical records for consistency, completion, coding accuracy,

. Coordinated safety programs, training, investigations, inspections

and audits,

. Conducted compliance reviews for consistent usage of process

instructions,

. Conducted change and capacity planning management,

. Completed Medical Coding (ICD-9-CM, CPT, HCPCS), Billing, Payroll,

Account Payable and Accounts Receivable duties.

Education and Training

Education:

Associate of Arts (A.A) in Health Care Administration, concentration in

Billing and Coding

November 2009, LA College International, Phoenix AZ

Bachelor of Business Administration (B.A) in Operations Management,

June 2008, American Intercontinental University Online, Hoffman Estates IL

Associate of Applied Science (A.A.S) in General Business Administration

August 1994, Volunteer State Community College, Gallatin TN

Certifications:

CQA Re-certification, December 2008 from ASQ (American Society for

Quality), Milwaukee WI

CQA Certification, December 2005 from ASQ (American Society for Quality),

Milwaukee WI

Training:

Six Sigma Black, Green and Yellow training

ISO 9000, ISO14000, TS 16949, ISO 20000, ISO13485, ISO-19011, QS 9000, AS

9100, FDA, USDA, UL, CCE, CA, Internal / Lead Auditing Training

OSHA 1904, 1910, 1910.178, 1910.97c, 1910.1030, 3000, 3021, 3071, 3151, 10-

hour, NFPA 70E, NFPA, 1, 10, 13 Safety Training and Trainer

Memberships:

American Academy of Professional Coders (AAPC) member since August, 2009

American Society of Quality (ASQ) member since August, 2000

Contact this candidate