Quality Assurance/Control Manager, Office Management

MONICA G. FRYAR

***** *** ** *

Rison, AR *****

870-***-**** Home 210-***-**** Cell

*******@*****.***

SUMMARY

Quality professional possessing in-depth knowledge of and experience

with corporate and manufacturing processes. Experience includes Auditor

of Quality Management Systems, Implementation and maintenance of ISO

9000/QS 9000 (TS 16949)/14001 Standards, AS9100 Standards, National

Precast Concrete Association (NPCA) Standards, Healthcare Accreditation

Standards, CMS, FDA, Federal and State Regulations.

EXPERIENCE

Physicians Sleep Center, LLC - Pine Bluff, AR Current

Sleep Technologist

Sleep Technologist for a sleep center to help evaluate and treat patients

with sleep disorders.

. Greets patients and gathers patient information

. Prepares equipment, performs patient set-up and provides patient

education

. Performs sleep study and implements appropriate interventions

(including actions necessary for patient safety and therapeutic

intervention such as positive airway pressure, oxygen administration,

etc.).

. Documents routine observations, including sleep stages and clinical

events, changes in procedure, and other significant events in order to

facilitate scoring and interpretation of polysomnographic results.

. Assists with the generation of accurate reports by tabulating

sleep/wake and clinical event data.

. Assists with scoring clinical events (such as respiratory events,

cardiac events, limb movements, arousals, etc.) utilizing AASM

standards.

Safran - Labinal Services, Little Rock, ARKANSAS 2011 - 2012

Quality Specialist/Trainer

Quality Specialist/Trainer for a world leader in aerospace and defense

electrical integration solutions.

. Performed Root Cause Analysis and performed Corrective and Preventive

Actions.

. Inspected wire harness assemblies and installations and documented

nonconformance.

. Supported the tasks of the Site Quality Supervisor to include

supervision of the Quality Inspection team and site Quality

Representative.

. Created and maintained training modules, including testing materials.

. Performed training by leading new hire training classes, hands on

workshop training, refresher training and new process implementation

training.

. Maintained training records, certifications and training database.

. Maintained stamp control, stamp records and stamp database.

. Maintained tool calibrations.

. Conducted Internal Audits, 5S Audits, Stamp Audits and Tool Control

Audits

. Participated in quality, Kaizen, and lean manufacturing functions to

maintain and improve the Quality Management System and to meet

internal and external quality requirements.

Artisan Concrete Works, Yakima, WASHINGTON 2010 -2011

Quality Manager

Quality Manager for a start-up concrete batch plant, in manufacturing

precast fence and wall solutions.

. Established, implemented and maintained a quality control, safety and

Preventive Maintenance (PM) program to meet the National Precast Concrete

Association (NPCA) requirements in record time, to secure contracts for

the Department of Transportation (DOT) in Washington State and California

resulting in excess of $2.1 Million per quarter.

. Established and implemented a Quality Control Lab to perform concrete

testing and the monitoring of concrete properties.

. Implemented concrete testing methods to meet the American Concrete

Institute (ACI) standards for precast products and aggregates.

. Completed the NPCA Production and Quality School certification course and

exams

. Represented the company as Safety Coordinator providing safety training

and incentives

. Managed Quality Inspectors and all product inspection activities

. Managed all day-to-day office management functions to include

timekeeping, payroll, production scheduling, purchasing, inventory and

production reporting, and shipping and receiving activities.

The Scooter Store, New Braunfels, TEXAS 2004 -2010

Corporate Standards and Accreditation Manager

Corporate Standards and Accreditation Manager for a leading supplier of

power mobility products for over 70 locations in the U.S. and Puerto Rico

. Implemented, managed and maintained the company's collective

accreditation and standards quality programs to ACHC regulatory

guidelines

. Developed and performed appraisal surveys and assessments rendering

status reports, corrective action plans and improvement recommendations

. Developed tests and standards to use in evaluating and improving critical

procedures for conformance to established regulatory requirements

. Maintained the company's standards and accreditation documentation

providing access and dissemination to all parties

. Developed, maintained, and interpreted departmental and key corporate

policies in accordance with external regulatory guidance and internal

business needs

. Orchestrated standards and accreditation education and training

programs, including education of key staff across departmental boundaries

. Developed and monitored performance metrics and reports for standards

and accreditation programs

. Fulfilled duties and responsibilities relative to quality improvement

coordination, and assisted with the overall development and

implementation of the quality improvement plan.

Precision Mold and Tool Group, Inc., San Antonio, TEXAS 2000 -2004

Quality Manager

Quality Manager for well-established company specializing in the design and

manufacture of injection molds and precision molding of plastic parts for

automotive, medical, electronic, and consumer devices.

. Established, implemented and maintained an ISO 9000:2000/QS 9000

Quality Management System (QMS)

. Represented company as Management Representative for the QMS

reporting to top management

. Established, documented and maintained all QMS documentation

including SOPs, Work Instructions, Process Flow charts, Safety

Procedures, training programs, forms and databases

. Developed and Performed advanced quality planning processes, PPAPs,

FMEAs, Gage R&R, DOE, capability studies, and SPC data collection and

analysis in support of continuous improvement

. Functioned as Lead Auditor for the QMS and supplier audits

. Established and performed training for the QMS to include

manufacturing work instructions, safety procedures and internal auditor

training

. Managed Quality Inspectors and all product inspection activities

. Monitored and measured the effectiveness of training

. Applied Corrective and Preventive Actions and root cause analysis

. Established and maintained the calibration and control of inspection,

measuring and test equipment

. Maintained inventory for raw materials and finished goods and

performed inventory functions to include shipping and receiving

. Performed receiving, in process and final inspections as required

. Coordinated Engineering Change Requests

. Represented quality as a member of the Material Review Board ensuring the

control of nonconforming product.

NUPAK MEDICAL, LTD., SAN ANTONIO, TEXAS 1998- 2000

Quality Manager/Office Manager

Quality Manager/Office Manager for a full service contract medical device

manufacturing and contract packaging company in a controlled access

environment.

. Established, implemented and maintained quality system procedures and

work instructions for continued improvement in the quality management

system to FDA and ISO requirements

. Incorporated quality procedures and processes to the quality program

at NuPak to add injection molding manufacturing capabilities to the

already existing assembly and contract packaging program

. Revised and implemented the employee training program

. Performed internal quality audits

. Prepared Management Review and other statistical analysis reports

. Received training for FDA related issues as well as GMP training

. Managed personnel and benefits,

. Performed all purchasing and financial functions including payroll,

payroll taxes, accounts payable and receivables

. Maintained inventory and inventory management software

. Performed supplier qualifications and supplier audits

BAKER SPD, SAN ANTONIO, TEXAS 1995 -1998

Quality Assurance Document Specialist

. Served as integral team member for attaining ISO certification and

preserving Canadian business, accounting for approximately 30-35% of

gross income

. Established, prepared and maintained all quality documents and

records within the quality management system to include QAM, SOP's, and

all technical documentation

. Prepared Management Review reports

. Functioned as Lead Auditor for the quality management system

. Created and maintained job descriptions and training manuals

. Created safety training materials and maintained Material Safety Data

Sheets (MSDS)

. Established and created a closed-loop process for handling customer

concerns

. Created an Electronic Engineering Change Notice (ECN) form for

tracking status of ECN.

EDUCATION/TRAINING

SOUTHERN ARKANSAS UNIVERSITY, MAGNOLIA, ARKANSAS

Bachelor of Business Administration / Computer Information Systems

BLS Certified (American Heart Association for CPR and AED)

ASQ Certified Quality Auditor

ISO 9001:2008 Online Refresher

ISO 9000:2000 Lead Auditor Quality Systems Course Certificate

AS9100 Aerospace Quality Management System Training

QS-9000/ TS 16949 Automotive Standards Training

Franklin Covey Time Management

Certified Specialist in Healthcare Accreditation

National Precast Concrete Association (NPCA) Production and Quality School

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