Quality Manager/Quality Auditor
Resume:
MONICA G. FRYAR
Rison, AR *****
210-***-**** / *******@*****.***
SUMMARY
ASQ Certified Quality Auditor possessing in-depth knowledge of and experience with corporate and manufacturing processes. Experience includes implementation and maintenance of ISO 9000/QS 9000 (TS 16949) standards, National Precast Concrete Association (NPCA), Accreditation Commission for Healthcare (ACHC) Accreditation Standards, FDA, Federal and State Regulations.
EXPERIENCE
Artisan Concrete Works, Yakima, WASHINGTON July 2010 – Present
Quality Manager
Quality Manager for a start-up concrete batch plant, manufacturing precast fence and wall solutions.
Successful establishment, implementation and maintenance of a quality control, safety and Preventive Maintenance (PM) program to meet the National Precast Concrete Association (NPCA) requirements for assuring quality precast products 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.
Successful establishment and implementation of a Quality Control Lab to perform concrete testing and the monitoring of concrete properties.
Successful completion and implementation of concrete testing to meet the American Concrete Institute (ACI) standards for precast products and aggregates.
Successful completion of NPCA Production and Quality School.
The Scooter Store, New Braunfels, TEXAS May 2005 – July 2010
Corporate Standards and Accreditation Manager
Corporate Standards and Accreditation Administrator for a leading supplier of power mobility products for over 70 locations in the U.S. and Puerto Rico
Managed and maintained the company’s collective accreditation and standards programs and status
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 accurate and dependable conformance to established regulatory requirements
Maintained the company’s standards and accreditation documentation providing easy access and full 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.
Integra Spinal Specialties, San Antonio, TEXAS Sep 2004 – May 2005
Quality Assurance Manager
Quality Manager for medical device manufacturing company specializing in customized pain management kits in a controlled access environment
Established, implemented and maintained Quality System Requirements
Applied Corrective and Preventive Actions and root cause analysis
Rewrote existing quality system procedures and work instructions for continued improvement in the quality management system
Performed installation, operational, and process qualifications for production equipment and manufacturing processes
Established and implemented an employee training matrix and training program
Performed all product inspection activities
Conducted Internal Quality Audits
Reported to top management on the performance of the quality management system.
The Scooter Store, New Braunfels, TEXAS May 2004 – Sep 2004
Quality Improvement Consultant/SR. Quality Assurance Analyst
Quality Improvement Consultant for a leading supplier of power mobility products
provided departmental guidance and direction to management teams for process and performance metrics
Designed and developed internal metrics and reporting methods
Documented departmental processes and procedures
Coordinated departmental training initiatives
Facilitated data gathering meetings and cross-functional process interviews
Lead quality assurance projects as necessary
provided departmental support for directors and managers.
Precision Mold and Tool Group, Inc., San Antonio, TEXAS Dec 2000 – Oct 2003
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
Successfully established and implemented 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, capability studies, and SPC data collection and analysis
functioned as Lead Auditor for the QMS.
Coordinated Engineering Change Requests
Established and performed training for the QMS to include manufacturing work instructions, safety procedures and internal auditor training
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
Performed receiving, in process and final inspections as required
Represented quality as a member of the Material Review Board ensuring the control of nonconforming product.
NUPAK MEDICAL, LTD., SAN ANTONIO, TEXAS Sep1998- Dec 2000
Quality/Office Manager
Quality/Office Manager for a full service contract medical device manufacturing and contract packaging company in a controlled access environment.
Rewrote existing quality system procedures and work instructions for continued improvement in the quality management system
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 financial functions including payroll, payroll taxes, accounts payable and receivables
Prepared financial statements
Purchased raw materials and company supplies.
BAKER SPD, SAN ANTONIO, TEXAS May 1995 – Sep 1998
Quality Assurance Document Specialist
served as integral team member for attaining ISO certification and preserving Canadian business, which accounted for approximately 30-35% of gross income
Established, prepared and maintained all quality documents and records within the quality management system
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 and Computer Information Systems
ASQ Certified Quality Auditor
ISO 9000:2000 Lead Auditor Quality Systems Course Certificate - 2002
QS-9000 Automotive Standards Training Course – 2001
TS 16949 Automotive Standards Training Course - 2002
Franklin Covey Time Management - 2004
Consulting Skills Workshop – 2004
Certified Specialist in Healthcare Accreditation – 2009
National Precast Concrete Association (NPCA) Production and Quality School – 2010
American Concrete Institute (ACI) Concrete Field Testing Technician – Grade 1 - 2010
Contact this candidate