Quality Manager
Resume:
Virginia C. Stujenske
**** ********* **, ******, ** 38057
**********@*****.*** 901-***-****
PROFESSIONAL SUMMARY
- Regulatory Manager - Quality Assurance Manager – Quality Engineer Associate
- Quality System Management - Quality Documentation Development
- Validation Protocol Development - CAPA - Training
- Communication - Writing - Motivated - Productive
EMPLOYMENT HISTORY
Matrix Machining Technologies, Inc. Memphis, TN 2015-2016
Quality Assurance Manager
• Managed the Quality System to ensure compliance with medical device regulations including
ISO 13485 and FDA 21 CFR 820
• Quality Representative during regulatory body and customer audits
Developed quality documentation including standard operating procedures, work instructions, and inspection plans
Managed Corrective and Preventive Action system
Interacted with customers, vendors and other employees concerning product quality related issues
Identified and drove continuous improvement initiatives to enhance customer experience, increase efficiency, and standardize processes
Managed change by gaining employee feedback, informing employees, influencing behavior, driving decisions, and setting company policies
Established validation standards, developed testing protocols, documented test results and maintained records for later analysis
Researched new manufacturing and inspection methodologies
Trained and mentored employees
J&B Precision, Inc. Memphis, TN 2012-2014 and 2015
Regulatory Manager
• Managed the Quality System to ensure compliance with medical device regulations including
ISO 13485, FDA 21 CFR 820 and ANVISA RDC16-2013
Developed quality documentation including standard operating procedures, work instructions, and inspection plans
Quality Representative during regulatory body and customer audits
Interacted with customers, vendors and other employees concerning product quality related issues
Managed Corrective and Preventive Action system
Identified and drove continuous improvement initiatives to enhance customer experience, increase efficiency, and standardize processes
Managed change by gaining employee feedback, informing employees, influencing behavior, driving decisions, and setting company policies
Established validation standards, developed testing protocols, documented test results and maintained records for later analysis
Researched new manufacturing and inspection methodologies
Trained and mentored employees
Developed Gage Calibration and Employee Training Systems
Zimmer, Inc., Memphis, TN 2014 Quality Inspector
Performed inspections of purchased parts, subassemblies or finished company products
• Reworked or rejected subassemblies or finished products as required
• Accurately documented the results of the inspections and testing
• Monitored critical equipment and instrumentation to ensure proper operation and
calibration
Performed review of Device History Records and other documentation for compliance to
established procedures and Good Documentation Practices
Smith + Nephew Inc., Memphis, TN 2008 – 2011
Quality Engineering Associate-Gage Design
Collaborated with Quality Control, Product Development, Manufacturing and Supplier Engineers in planning for quality and resolving quality issues
Attended design and print review meetings to discuss dimensional and geometric tolerance methods
Produced and procured final inspection gauging, holding fixtures and overlays for implants and instruments
Performed GR&R studies to ensure proper, reliable, and repeatable gauging
Maintained and revised associated CAD files in product data management software
Mentored and coached individuals and groups for gauging, tolerancing and modeling principles
Participated in the development of a gauge ordering system, providing management with concepts and detailed reports of work in progress
Interacted with outside facilities and vendors regarding gauging issues
Smith + Nephew Inc., Memphis, TN 1996 – 2008
Quality Engineering Associate
Supported Quality, Product Development, Manufacturing and Supplier Engineers with new product launch activities for the Reconstructive Instrument Team
Created and revised inspection procedures, quality standards and work instructions
Initiated inspection procedure and print changes utilizing computerized change management system
Performed, reviewed and approved first article inspections
Evaluated non-conforming materials for corrective action, analysis and disposition
Instructed Manufacturing Associates in the use of gauges, inspection techniques and print interpretation.
Drove continuous improvement efforts for Instrument Manufacturing Team. Facilitated Failure, Mode and Effect (FMEA) meetings.
Gathered statistical data and provided reject and scrap analysis reports for manufacturing teams.
Promoted to Quality Engineering Associate in 1996.
Smith + Nephew Inc., Memphis, TN 1991 – 1996
Quality Technician I, II, III
Performed first articles and surface plate layouts utilizing various types of inspection equipment such as coordinate measuring machines and optical measuring systems
Calibrated all types of measuring instruments
Participated in process validation studies. Ensured completion and correctness of shop order paperwork
Promoted to Quality Technician II in 1993 and to Quality Technician III in 1995.
QUAKER OATS, Dallas, TX 1988-1991
Laboratory Technician
DANA CORPORATION, Lancaster, TX 1984-1988
Machinist
EDUCATION
Southwest Tennessee Community College, Memphis, TN
A.A.S. Mechanical Engineering Technology, 2014
CERTIFICATIONS
Six Sigma Greenbelt Training – Onsite, Smith + Nephew
Manufacturing Fundamentals-Southwest Tennessee Community College
American Society for Quality - Mechanical Inspector, Quality Technician
and Quality Improvement Associate
Geometric Dimensioning and Tolerancing- Jim Meadows Institute
NX Design and Assemblies- Siemens
Screw Machine Set-Up and Operation –Crump Area Vocational and Technical School
Mager Training (Train the Trainer) – Onsite, Smith + Nephew
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