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Engineer Quality

Location:
Senoia, Georgia, 30276, United States
Posted:
December 31, 2017

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Shannon Goodman

ac3u8d@r.postjobfree.com • 352-***-**** • Senoia, GA

CERTIFICATIONS & EDUCATION

Enrolled in Kennesaw State University, Masters in Quality Assurance – 50% complete - 4.0 GPA

Enrolled in Kennesaw State University, Six Sigma BLACK BELT

B.S. Mechanical Engineering - Milwaukee School of Engineering 9/93 – 11/97

ISO 13485 Certificate – Quality systems for medical device – FDA and GMP compliant certification

ISO 9001:2000 Certification – Family of Standards

ISO 9001:2000 Introduction and Awareness

ISO 9001:2015

Six Sigma Green Belt Certified

APQP Certified

Lead Internal Auditor

EXPERIENCE

Sigvaris Corp - 4/13 – 11/17 - Peachtree City, Georgia

Quality Engineer

Design and initiated validation program from scratch to meet FDA/GMP and ISO 13485 requirements for medical device manufacture, utilizing Installation Qualification, Operational Qualification and Performance Qualification for validation protocol. Use MiniTab to perform Capability Analysis, Sample Size Estimation, Normality Testing of all data. Direct senior management by using process PFMEA to optimize their production process; utilizing mistake proofing tools, visual aids and 6-S. Bill of material creation, cost estimating and risk analysis on design of product and test methods. Safety trainer, develop monthly safety training. Implemented scrap reduction program, resulting in a 25% reduction in scrap. Performed gap analysis of quality documents and checklists for compliance, resulting in creation of preventative maintenance program.

Risk Analysis – Design and test methods

Designed Validation program to meet FDA/GMP and ISO 13485 requirements for medical device

Normality, Capability Analysis, Sample Size Estimation, Predictions using MiniTab

Use PFMEA/DFMEA to direct senior management and departments

Gap analysis of quality documents and checklists, create preventative maintenance program

Internal Auditing

Maintenance of all quality documents related to QE

Cooper Lighting/Eaton Corp - 4/12- 4/13 - Peachtree City, Georgia

Manufacturing Engineer Innovation Center

Designed, optimized, balanced automated manufacturing cells for lighting fixture assembly. Innovation center performed cell testing and optimization. The cells were shipped to plants in North America for immediate start up.

Risk Analysis for safety of each cell and station

Black Belt Trained – Chosen by Quality Director to attend 2-week intensive training

Applied Design and Process PFMEA for projects

Implemented correct Protective Equipment for environment

Grenzebach - 5/08- 3/12 - Newnan, Georgia

Mechanical Engineer/Technical Buyer Purchasing

Engineer conveyor systems for the solar glass industry, including all calculations for buckling, bending, and overall support; choose all conveyor pneumatics; perform conveyor speed calculations; define all material specifications including metal and plastic materials; coordination with all departments to meet schedule deadlines; create quality engineering documents; shop support,

Purchase all mechanical materials; scheduling part arrival; work with vendors on a daily basis to ensure on-time delivery; qualify new vendors; quality documents for purchasing.

Engineer conveyor systems

Purchasing Technical Buyer

Work with vendors to ensure on-time delivery; qualify new vendors

Create quality documents for purchasing

Create quality documents for engineering

Monitor Products Inc - 10/06-11/07 - Brooksville, Florida

Quality Manager: ISO 9001:2000 / Mechanical Engineering Manager

Managed 3 departments including receiving inspection, final inspection and test department; analyze piece parts using attribute sheets to track defects (SPC); examined RMA Reports, warranty issues, reworks prompting Corrective Actions; analyzed on-time delivery, SCAR’s, vendor discrepant material reports and work with purchasing to improve supplier response; provided customer support by supplying PPAP, FMEA and Warrants (Daimler-Chrysler PPAP forms), First Article Reports; used 5 Why’s and Root Cause Analysis to determine potential improvement; applied lean principles to manufacturing eliminating unnecessary cost, scrap and lower rework; prepared preventative actions based on daily inspection reports, DMR’s, test reports and rework reports; managed yearly audit process including selecting audit teams, performed 90% of audits, prepared and presented management review collecting all data from CAR’s, SCAR’s, DMR’s, RMA’s and warranty issues.

Managed 3 departments

External Audit produced zero non-conformities

Utilized Six Sigma Green Belt methods to reduce costs on high volume units

Increased Customer Quarterly Ratings by 25 points out of 100 points

Pall Aeropower - 9/01-4/05 - New Port Richey, Florida

Aerospace Project Engineer (Manifolds and Valves)

Designed precision dual relief, check, manual and automatic relief valves, filter manifold for Boeing and filter manifold for Hamilton Sunstrand business jet; designed and drew all tooling to support valve and manifold functionality testing (ex. vibration, endurance, burst, pressure drop)

Six Sigma Green Belt Trained

Designed and Executed the FIRST ON TIME, UNDER BUDGET project for the department

(Boeing 737 filter manifold)

Guardian Electric Manufacturing Co. - 9/99 – 7/01 Woodstock, Illinois

Electro-Mechanical Design Engineer

Design and project manage OEM solenoids for Boeing, Lockheed Martin and many others both military and non-military applications from request-for-quote to production; perform all calculations for coils including calculation of the number of turns to produce the desired amount of force.

Certified internal auditor – Performed audits (Lead Auditor) for quality AS9000, ISO9001

APQP Certified

Perform testing and write ATP (Acceptance Test Procedure) reports

Received best practice award for internal auditing from Boeing

TECHNICAL SKILLS

MiniTab, Penta (BOM’s, Purchasing, Inventory, Design Coordination Hamlar), Project, One Space Solid Designer, Inventor, AutoCAD (20 years – From release 10 to 2007), Catia V-5 Certified, MathCAD, TK Solver, AS 400, Word, Excel, Power Point, Mapics, FastCAD, CADkey 3D



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