Virginia C. Stujenske

**** ********* **, ******, ** 38057

acvfr5@r.postjobfree.com 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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