Medical Device Engineer
Resume:
Resume of: **** Brooklyn Road
EDWARD H. BITNER Brooklyn, Michigan, 49230
517-***-**** (cell)
********@*****.***
EMPLOYMENT
*/** – 7/11 QUALITY ENGINEER & QUALITY ANALYST
Pall Life Sciences
Ann Arbor, Michigan
9/76 - 5/80 GRADUATE TEACHING FELLOW
The University of Michigan
Ann Arbor, Michigan
9/74 - 5/76 GRADUATE TEACHING ASSISTANT
The State University of New York, College at Brockport
Brockport, New York
EDUCATION
9/99 – 3/2007 Eastern Michigan University
M.S. course work in Industrial Technology
Department of Quality
9/76 - 5/80 University of Michigan
Ph.D. course work in communication
9/74 - 5/76 State University of New York, College at Brockport
Major: Interpersonal Communication
M.A. in Communication
9/72 - 5/73 Cornell University
Major: Biology
Minor: Communication Arts
B.S. in General Agriculture
9/68 - 5/71 Rutgers University
Undergraduate coursework in biology
RELATED COURSEWORK
Courses taken with Management Resources International in partnership with Eastern Michigan University Center for Quality: Design of Experiments I and II, Statistical Process Control I and II, Geometric Dimensioning and Tolerancing, Process FMEA with Control Plans, Blueprint Reading.
RABQSA Certified ISO 9001: 2008 3-day Internal Auditor training with Medical Device Focus (ISO 13485). Training occurred in December 2009.
Six Sigma Green Belt Training and project during fall 2010 and spring 2011. Examination taken and passed. Project completed.
EMPLOYMENT
8/86 – 7/11
Pall Life Sciences.
14 years as a quality engineer and quality analyst in the Quality Engineering Department. Performed internal audits and supplier audits to the ISO 9001 standards and the ISO 13485 (Medical Device Focus) standards from 2000 until 2011. Other duties include customer complaint investigation and resolution, disposition of first article Inspection, supplier management, process and product improvement projects, statistical analysis of data and its presentation, Green Belt Project to address customer complaint closure time, data analysis using Minitab, special projects for the quality department and engineering and presentations where required.
Previously worked for Pall Life Sciences and Gelman Sciences as a product tester and senior tester in a manufacturing quality control laboratory. Duties included running tests on various plastic medical and laboratory filtration devices and documenting the results using variable and attribute data forms and S.P.C. charts. Product disposition decisions and final release decisions were based upon testing results. Built special testing equipment and maintained the testing laboratory. Testing included bubble point measurement, housing integrity testing, mass flow testing, liquid particle counting, and U.V. extractable testing.
9/76 - 5/80
The University of Michigan
Graduate teaching fellow preparing materials and teaching courses in public speaking, persuasion and interpersonal communication. Maintained student records and performed informal academic advisement and wrote recommendations as requested and where appropriate.
9/74 - 5/76
The State University of New York
College at Brockport
Graduate teaching assistant teaching courses in interpersonal communication and conflict resolution. Maintained student records and grades and performed informal academic advisement.
CERTIFICATIONS
Certified Quality Engineer: American Society of Quality, June 1998. Most recent recertification June 2010.
Six Sigma Green Belt: Pall Corporation, June 2003
Internal Auditing Training; ISO 9001:2000: Michigan Manufacturing Technology Center, February 2003.
RABQSA 3-Day Internal Auditor Training ISO 9001:2008 (Medical Device Focus ISO 13485), December 2009.
ORGANIZATIONS
American Society of Quality, Section 1010 since 9/15/1997
Fraternal Order of Moose since 1990.
REFERENCES
Deanna Trinkle
Senior Buyer: Pall Corporation; Ann Arbor
Worked directly with the Senior Buyer for over 10 years and also performed several customer audits with her during that time.
Denny Keefe
Quality Manager: Classic Industries; Latrobe, P.A.
Supplier for Gelman Sciences and Pall Corporation. Worked directly with him on customer complaints and supplier issues related to his company.
Bob Lambert
President of Lambert Industries; Ann Arbor
Worked directly with him on customer complaint and supplier issues related to his company.
Sean Kelleher
Personal Reference
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