Melisa Gilchrist
***Allen’s Landing Court
Lawrenceville, Ga. 30045
SUMMARY: Experienced Quality Assurance professional with a demonstrated history of working in the medical device industry. Skilled in Microsoft Excel, Microsoft Word, Medical Devices, Business Process Improvement, and GMP. Strong quality assurance professional with working knowledge of ISO/QSR/FDA quality systems and auditing experience
EMPLOYMENT
2010- Present Quality Engineer, Theragenics Corporation
Resolved customer complaints, took preventive measures to avert future complaints, and clearly documented all feedback.
Provided support in establishing and putting in continuous process improvements
Prepared and maintained quality documentation such as quality procedures and Engineering Change Request
Oversees the Internal Audit Program and Calibrations Manager Program
Evaluated quality and overall efficiency in coordination with manager of departments.
Identified, investigated and determined final disposition of NCR’s, CAPA’s, Customer complaints and SCAR’s
2001-2009 Training Coordinator, Ciba Vision
Maintain and update curriculum dataset and training records
Developed, implemented, and maintained quality systems procedures in compliance with regulatory requirements
Maintain documents and records for ISO/FDA/GMP compliance
Performed internal auditing and presented reports to management
Conducted organizational wide needs assessment and identified skills and knowledge gaps that needed addressed
Assessed instructional effectiveness and summarized evaluation reports determining the impact of training on employee skills and how it affects KPIs
1998-2001 Group Leader, Motorola
Provided hands on training for new operators ensuring compliance with OSHA regulations.
Maintained daily performance documentation to ensure goals were being met.
Monitor and respond to daily production demand report to determine build prioritization.
Manage the work-order build to stock and build to ship utilizing Yantra/Oracle Warehouse Management Systems
Manage on-line inventories to ensure accurate inventory counts and prevent order delinquencies.
Assist Process Engineers in developing process improvements and line configurations and New Product introduction.
EDUCATION
High School Diploma, McCormick High McCormick S.C.
REFERENCES Upon Request
PROFESSIONAL DEVELOPMENT
Management
Train the Trainer ( Effective Presentations )
Preventing sexual harassment
H.R. Policies and Procedures
Introduction to Motorola Management
Dealing with Differcult People
Utilizing the Six Steps to Six Sigma
Effective Business Writing
Six Steps To Problem Solving
Team Building
ISO 9000
NCJ001/ IPC610 Rev.B Standards
Technical
Philips CSM 84
Panasonic MPAV
Panasonic MV2F
Seimans Conformal coat Machine
Dynapert D4500 Dip Inserter
Dynapert V12000 VCD
Zebra Printer
Dek Screen Printer
Wave Solder Machine
Universal Senquencer
Allen Bradley Automation
Krauss Maffei Mold Machine
Engel Mold Machine
Arburg Mold Machine
Computer Skills
Excel, Word, Yantra and Oracle