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Manager Quality Engineer

Location:
Stone Mountain, Georgia, United States
Posted:
May 31, 2017

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Melisa Gilchrist

***Allen’s Landing Court

Lawrenceville, Ga. 30045

(404)***-****

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



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