Sr. Quality Engineer Resume

Profile

Over twenty years of technical experience in the manufacturing quality arena. Specific experience includes:

ISO 9000 & ISO 13485 Certification / Process Improvement
FDA / Medical Quality Requirements; cGMP
PFMEA, Gage R & R, Geom. Dim. and Tolerancing
Incoming Inspection / Supplier Certification & Auditing
Statistical Process Control / First Article Inspections
Metal stamping and MIG / TIG welding
Continuous Improvement / Internal Audits

Education

B.S. Mechanical Engineering

Career History

Consultant Sr. Q.E. positions
Feb 2007 to April 2011

Short term positions at three manufacturing companies where I was a senior quality engineer:

Confidential, Clearwater, FL
- worked on Space Shuttle Engine Controller Program
Confidential, Sarasota, FL
- manufacturer of airplane switches and relays
Confidential, Tampa, FL
precision machine shop and foundry

Confidential, Largo, FL
Contract Position
July 2005 to Aug 2006
Sr. Quality Engineer

Obtained corrective action from the Hemodialysis Centers in the U.S.A.
Worked in the field corrective action team to close out manufacturing modification issues
Ensured that the corrective action received was accurate as documented and filed
Worked within an ISO 13485 quality system
Originate CAPAS and perform follow-up

Confidential
Tampa, FL
Oct 2002 to July 2005
Contract Statistical Analyst

Calculating means and standard deviations for test scores by school, between schools/school districts for any number of years
Grading standardized tests to approved criteria using a scale of one to five
Developing additional reports for State Education Departments.
Left for job with Baxter

Confidential, Cincinnati, OH
Manufactured MRI Mobile Modules for G.E.
Contract Position
Oct 1999 to Oct 2002
Sr. Quality Engineer

Responsible for quality improvement internally and externally.
Witnessed First Article Inspections to guarantee accuracy and that they were documented per ISO 9002 requirements
Implemented an SPC program for critical dimensions
Resolved all issues found by the state code inspector
ISO 9002 system maintenance and change implementation
Providing statistical analysis (pareto charts, fishbone diagrams) to management for their review
Performing trend analysis, issuing corrective action on in-house rejections
Creating process FMEA's with Mfg. Eng.
Planning and performing supplier audits to ISO 9002
Left due to contract ending

Confidential, Cincinnati, OH
Jan 1997 to Oct 1999
Quality Manager of Medical Device Division

Reported to the Director of Quality with two direct reports and fifteen indirect reports.
Witnessed First Article Inspections to guarantee accuracy and that they were documented per ISO 9002 requirements
Gained ISO 9002 certification on a new product line
Led the Material Review Board reducing average disposition time by 50%
Performed supplier audits to ISO 9002
Participated in design reviews involving all functions
Originating CAPAS and performing follow-up
Wrote inspection plans, work instructions and procedures
Left due to medical division being bought out by Hill-Rom, Inc.

Confidential Loveland, OH
Ball Bearing Manufacturer
Jan 1993 to Jan 1997
Quality Manager

Reported to the President with 2 direct and 55 indirect reports in a facility of 200 employees
Responsible for leading the ISO 9002 certification effort
Wrote and obtained approval on all ISO procedures after interviewing department heads
Achieved ISO 9002 certification in eight months including the training of all employees
Led the set-up reduction team, attaining a 35% reduction in lead time for a savings of $220,000 per year
Performed internal and external audits resolving all issues found
Left for better opportunity

Confidential Cincinnati, OH
Aug 1989 to Jan 1993
Sr. Quality Engineer

In process QA engineering on 2 WIP projects to reduce component and assembly problems
Witnessed First Article Inspections to ensure accuracy and that they were documented per the quality manual
Worked within cross-functional teams to write and implement validation protocols and FMEA's on programs
Reduced supplier base from 350 to 165 in six months
Implemented ANSI specs to reduce incoming lot inspections by 75%
Performed long and short term process capability studies
Performed trend analysis on supplier and in-house rejections
Originate CAPAS and perform follow-up
Left due to corporate downsizing

ADDITIONAL TRAINING

ISO 9000 Lead Assessor, certification #L-2607 thru STAT-A-MATRIX
Dale Carnegie Human Relations Course
SPC for Manufacturing Seminar
Microsoft Word , Excel and PowerPoint

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