Engineer Quality

Henry Wheeler

Email: *********@********.***

Address: **** * ******** ****** *****

City: Mason

State: OH

Zip: 45040

Country: USA

Phone: 804-***-****

Skill Level: Experienced

Salary Range: $80,000

Primary Skills/Experience:

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Educational Background:

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Job History / Details:

SUMMARY

ASQ CERTIFIED QUALITY ENGINEER with over fifteen years of experience as a champion of continuous improvement for manufacturing and R&D settings in the biotechnology, petrochemical, consumer goods, and medical device industries.

PROVEN SPECIALIST in the application of analytic tools and problem solving techniques for continuous improvement.

RESULT-ORIENTED CONTRIBUTOR who views problems as opportunities to exceed expectations.

SEEKING career opportunities in biotechnology, consumer goods, medical devices, chemical processing, and manufacturing

CORE COMPETENCIES

Data mining, predictive modeling, hypothesis testing, reliability, risk analysis, root cause analysis, process mapping, inspection and testing, validation, FMEA, CAPA, DOE, SPC/SQC, MSA, quality system auditing, technical writing, ISO9001, ISO13485, ISO17025, and 21 CFR

SAS JMP, Minitab, Statistica, Microsoft Office Suite (Word, Excel, PowerPoint, Access, and Visio), Infinity QS, SQL, Business Objects, SharePoint

PROFESSIONAL EXPERIENCE

04/2012 - current Quality Engineer (contract) Silfex Inc., Eaton, OH

SPC software application development and deployment in a production environment to improve in data integrity through the elimination of manual entry of in-process and outgoing inspection data

Streamlining SPC practices through reviews/updates to existing control charts for statistical validity and updates to out-of-control action plans to assure appropriate responses adverse process changes

Contributing to process qualification and receiving inspection plan development

11/2011 - 04/2012 Quality Engineer (contract) Zimmer Inc., Warsaw, IN

Consulted with suppliers to bring closure to CAPA project deliverables with expired due dates.

Added updates the existing supplier CAR tracking system and reduced turn-around times.

Participated in internal CAPA investigations resolve multiple open CAPA`s that were initiated to address FDA audit findings.

02/2010 - 11/2011 Quality Engineer (contract) Ethicon-Endo Surgery, Cincinnati, OH

Developed and deployed Excel templates to standardize statistical applications used in support of product development, continuous improvement and regulatory compliance. Templates were implemented internally and are currently maintained as quality system documents.

Leveraged analytic skills to facilitate risk analysis for FDA inquiries and complaint investigations

Provided statistical reliability estimates in support of accelerated aging studies for new product development initiatives.

Supported ongoing CAPA projects through trend analysis and risk evaluations of current and historical occurrence rates for FDA-reportable events relative to estimated limits captured in FMEA`s.

12/2000 - 02/2010 Associate Research Scientist Altria Client Services, Richmond, VA

Estimated measurement uncertainty for of 100 analytical testing procedures and measurement systems leveraged in a Research and Development environment. The estimates were applied to establish precision limits for test methods and to satisfy a key requirement for the facility`s accreditation under the ISO 17025 quality standard.

Conducted chemical stability studies that established shelf lives of critical reagents and significantly reduced the costs associated with the purchase and storage of potentially hazardous chemicals.

Developed and implemented metrics for tracking and evaluating the performance of contract testing facilities. These metrics were used to verify and validate reported data and for screening candidate external testing facilities.

Designed and coordinated an inter-laboratory study to establish precision limits for an analytical testing procedure to be reviewed for ISO standardization. Findings were peer reviewed, published and presented at an industry conference.

EDUCATION

Bachelor of Science, Chemistry: Southern Illinois University, Edwardsville, Illinois.

Graduate coursework, Applied Statistics: Rochester Institute of Technology, Rochester, New York.

CERTIFICATION

American Society for Quality, Certified Quality Engineer: Certificate No. 58547

PUBLICATIONS

Chwojdak, C., Self, D.A., and Wheeler, H.: A Collaborative Harmonized LC/LC/MS Method for the Determination of Tobacco-Specific Nitrosamines in Tobacco and Tobacco-Related Products - Presentation delivered at the 61st Tobacco Science Research Conference in Charlotte, North Carolina on September 24, 2007

Greene, S., Wheeler, H., and Riley, W.: Performance in College Chemistry: A Statistical Comparison Using Gender and Jungian Personality Type, Journal of Women and Minorities in Science and Engineering, Vol. 10, pp. 217-227

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