John P. Guy

**** ******** **. *.*.

Cleveland, TN 37312

423-***-****

acr008@r.postjobfree.com

CAREER SUMMARY:

Successful career in Quality & Regulatory Systems/Engineering management with achievements in system development to international standards (ISO 9000 based), development of significantly successful problem solving systems (6-sigma/LEAN/K-T based) and systems for process control, metrology (gauge control), qualification/validation, supplier development and customer interface.

CAREER HISTORY

2014 – Current Quality/Regulatory Manager – Richmar, Inc.

Quality System compliance to FDA 21CFR211, 21CFR820, ISO 13485 (CMDR)

International Regulatory registration (Europe, Canada, Mexico, Asia)

Quality System development and Improvement; QMS development

Supplier Quality and Incoming Quality

Management Review process with SME Development

Nonconformity, Problem Solving, CAPA, Remediation Disciplines

Procedure development, refinement and improvement

Technical testing and component inspection

Product, Test and Process validation

Accomplishments: Facilitated implementation and validation of first pharmaceutical product manufacturing process

Implemented and validated product test process for FDA compliance

Implemented nonconformity process, remediation and CAPA

Facilitated Specification development for all components

Developed discipline for full Good Manufacturing Process compliance

2001 – 2014 Mgr. Incoming/Supplier Quality – Merck Mfg. Div./Merck Consumer Care

Quality Engineering and statistical methods implementation including FMEA and SPC

Supplier interface/problem resolution; supplier approval and improvement

Incoming Quality Inspection management and system improvement

Nonconformity (Deviation) Process (Root cause and corrective action process)

Process/Equipment/Instrument qualification/validation (IQ/OQ/PQ)

Corrective/Preventive Action, Process Capability, Specification approval.

Accomplishments: Reduced incoming inspection cycle time 75%; reduced OT 50%

Instilled complete GMP into Incoming Quality processes

Development and administration of effective Deviation system

Successful FDA audit of Deviation process with no findings

Incorporation of fundamental quality system discipline into corporate standards and philosophy

Introduction of Problem Solving discipline at corporate level

New Instrument (FTIR, NIR, RAMAN) introduction, qualification/validation and implementation

Lean Lab and 6-sigma implementation, Kaizen process

Compliance monitoring system development and implementation

1998 – 2001 Senior Consultant – Excel Partnership, Inc.

Primary focus on development and implementation of management systems meeting requirements of QS/ISO9000 (1994 & 2000), VDA 6.1, ISO 17025 and TS16949. Clients included DaimlerChrysler, General Motors, Siemens Automotive, Johnson Controls along with public course instruction. Activities include Project Management, Lead/Internal Auditor training, multi-disciplinary coordination, system auditing, course development, corrective/preventive action implementation and process improvement. Results include successful registration of several clients, significant reduction in problems via root cause analysis, supplier improvement and effective internal audit systems.

1995 - 1998 Director of Quality Systems - Crossville Rubber, Inc.

Executive responsibility for overall quality operating system, budget, appropriations, hiring, training and administration. Development and implementation of a Quality Operating System structured per requirements for QS9000/ISO9000 certification and restoration of customer confidence. Developed and authored the Quality Manual, procedures and instructions. Responsible for Program/Project Management during new product launch (per APQP methodology), FMEA, PPAP, customer and supplier quality management, Total Quality philosophy and discipline resulting in certified quality system, reduced costs, customer confidence and improved supplier performance.

1994–1995 QUALITY ENGINEERING/MANAGEMENT CONSULTANT CONTRACT ENG.

* Ferodo America - Control Plan, Statistical Methodology, DOE & SPS

* Textron Automotive Interiors - Advanced Quality Planning, Control Plan and Production Part Approval Process (GM emphasis)

1980 1994 AlliedSignal Corp., Braking Systems Division

MANAGER, QUALITY ASSURANCE (QUALITY TEAM LEADER) 1993 - 1994 .

SENIOR ENGINEER, QUALITY

LIAISON ENGINEER, PRODUCT ENGINEERING

PRIOR EXPERIENCE IN PRODUCTION/MANUFACTURING SUPERVISION/MANAGEMENT, INCLUDING RUBBER MANUFACTURING, METAL STAMPING, MACHINING, AND FINISHING.

Extensive experience and knowledge in the following:

●FDA cGMP (CFR Parts 210, 211, 820)

●ISO 16949, VDA 6.1, ISO 13485, ISO 17025

●QS/ISO9000 Lead Auditor, QS/ISO9000 Lead/Internal Auditor

●APQP, PPAP, DOE, MSA, 6 (Six Sigma)/LEAN (Green Belt), Kaizen, TQM

●FMEA, SPC, Problem Solving (KT), Ford "8D/TOPS"

●Statistical Problem Solving, Experimental Design and Statistical Analysis

●Geometric Dimensioning and Tolerancing (GD&T), CMM/DCC

●Background in metal stamping, machining, powdered metallurgy

MILITARY

Served 6 years in U.S. Army Reserve (SGT/E5)

EDUCATION

B.A. (Psychology/Chemistry/Biology) Wabash College, Crawfordsville, IN

- subsequent education at Rensselaer Polytechnic Institute, Lee University, Cleveland State Community College, Purdue University

* Certified Quality Engineer (ASQ - CQE #15338)

OTHER

Proficient in the use of both PC and mainframe computer applications including MS Office Pro (Word, Excel, Access, Outlook, Visio, PowerPoint, Project), Lotus Notes, Lotus Suite, SAS/JMP, MiniTab, Word Perfect, SAP, LabWare. Proficient in statistical theory and application.

Have studied German, but not fluent conversationally.

Active with family, church, personal fitness/sports, home improvement and auto maintenance.

I enjoy and value the contributions, perspectives and needs of all individuals and pride myself at having communication skills to interact with persons from a variety of cultures, backgrounds, perspectives, educational levels and experiences.

Contact this candidate