Quality Engineer Regulatory Affairs

Chris Card

**** ******** ********* **. 615-***-****

College Grove, TN 37046 *********@******.***

EMPLOYMENT

Allison Transmission, Inc. dba Walker Die Casting, Lewisburg, TN 9/2019 to 01/09/2023

Quality System Manager

Continuous improvement champion and mentor: Completed within 180 days the first ever site-specific six sigma project realizing $350,000 in annual savings with a 25 week investment payback; current direct or indirect support of four chartered improvement projects with a combined projected annual savings of $670,000; Maintenance of TS16949 Quality Management System certification through two top management and sweeping procedural changes within three years

Walker Die Casting, Inc., Lewisburg, TN ($173M) 3/1998 to 9/2019

Director of Quality Management (3/2019 to 9/2019)

Overall responsibility for the Quality function engaged in the casting, machining, assembly and resin impregnation of component parts for the automotive, truck, recreational vehicle and medical device industries; compliance with the varied requirements of these industries; direct or indirect supervision of fifty-six employees; member of the ISO 14000 Leadership Team for Environmental Management (certified 02/2020)

Technical Account Manager (6/2002 to 03/2019)

New account development and existing account management ($55M): sales presentation, quote preparation and contract negotiation; project management; technical contract review; responsible for maintenance and reporting of ISO9001/IATF16949 quality system departmental metrics; Simultaneous Engineering liaison to General Motors; $15M net growth in previously established accounts; $20M additional new customer business development

Quality Engineer (3/1998 to 6/2002)

Quality system standards compliance: QS9000, ISO9001, TS16949; various internal and external responsibilities regarding part quality: process validation (APQP & PPAP); sub-supplier and process control (Audit & SPC); Root Cause Analysis and Corrective and Preventive Action formulation; trainer

France Lighting Solutions, Fairview, TN (9/1996 to 09/1997)

Quality Engineer

Various duties while engaged in the manufacture of UL-listed electric and electronic transformers: Root cause analysis and corrective action formulation; product quality evaluation and monitoring, process validation, supplier evaluation and control; etc.

EDUCATION

Johns Hopkins University, Washington, DC.

Degree earned: Regulatory Affairs (MS). 3.8 cumulative GPA

Southern Illinois University, Carbondale, IL.

Degree earned: Industrial Technology (BS). 3.75 cumulative GPA

EDUCATION CONTINUED

State Technical Institute, Memphis, TN.

Degree earned: Mechanical Engineering Technology (AAS)

Degree earned: Industrial Engineering Technology (AAS)

3.888 cumulative GPA

CERTIFICATION

American Society for Quality (ASQ) Certified Six Sigma Black Belt #22068

ASQ Certified Six Sigma Green Belt #18360

ASQ Certified Pharmaceutical Good Manufacturing Practices Professional #24

Regulatory Affairs Professionals Society (RAPS) US Regulatory Affairs Certified

ASQ Certified Biomedical Auditor #395

ASQ Certified Quality Engineer #35271

ASQ Certified Quality Auditor #15621

Society of Manufacturing Engineers (SME) Certified Manufacturing Engineer #4300290

CONTINUING EDUCATION

Numerous congress, exposition, conference, symposium, seminar and class offerings in the subjects of cost estimating, manufacturing processes, materials, regulatory affairs, Spanish language, metrology, quality control methodologies and quality systems. Sponsoring organizations included the Regulatory Affairs Professionals Society (RAPS), Society of Clinical Research Associates (SOCRA), Collaborative Institutional Training Initiative (CITI), American Society for Quality (ASQ), American Quality Institute (AQI), North American Die Casting Association (NADCA), Automotive Industry Action Group (AIAG), Society of Manufacturing Engineers (SME), National Training Seminars Group, Middle Tennessee State University, University of Wisconsin Milwaukee, and the University of Tennessee Center for Industrial Services.

ACTIVITIES AND HONORS

Chevalier de l’Ordre Ducal de la Croix de Burgogne (dubbed April 2022)

Member Organizing Committee, 2018 ISO9000 World Conference, American Quality Institute

Member Society of Manufacturing Engineers (SME) section 43

Member Regulatory Affairs Professionals Society (RAPS)

Member American Society for Quality (ASQ) section 1118, Automotive, Biomedical and Healthcare divisions

ASQ Certified Pharmaceutical Good Manufacturing Practices certification examination item reviewer

Scholarship Committee Chairman Tennessee Viticultural and Oeneological Society (TVOS)

Past President Tennessee Viticultural and Oeneological Society (3X)

Homer Blitch Award recipient (TVOS)

Former member Institutional Review Board, Tennessee Valley Healthcare System, Nashville TN

Former member Tennessee Biotechnology Association

Former member Golden Key National Honor Society, Tennessee State University

Former member Phi Theta Kappa National Honors Society, State Technical Institute

Former member National Association of Industrial Technology (NAIT)

Contact this candidate