Quality Engineer

Stephan A. Klamic

**** ****** ***** *********, ** 33578

Home: 813-***-**** ¨ Cell: 813-***-**** ¨ E-Mail: *******@***.***

SUMMARY OF QUALIFICATIONS

A knowledgeable and results-oriented professional with over 25 years of management experience in manufacturing, materials, quality assurance, and improvement programs.

AREAS OF STRENGTH

· Process and quality improvement tools that include a Master Black Belt in the Six-Sigma methodologies and training of plant staff and line supervisors. Statistical analysis background using advanced software tools including Minitab.

· Certified internal ISO (9001:2000 and 13485:2003) auditor.

· FDA-regulated medical device industry experience including submissions of 510K applications, establishment inspection, implementation of cGMP’s, CAPA, and complaint handling and reporting.

· Excellent presentation development and delivery skills; ability to speak in front of wide-ranging audience type from senior management to shop-floor employees.

BACKGROUND & SKILLS

INDUSTRY

Independent Contractor – January 2009 to present, Tampa, FL

QUALITY ENGINEERING AND QUALITY SYSTEMS contracting for various manufacturers. (Current assignment is with Kimball Electronics in Tampa, FL)

Leader Tech, Inc. – March 2007 to January 2009, Tampa FL

QUALITY MANAGER/ENGINEER for this manufacturer of EMI/RFI shielding products. Areas of responsibility include: Quality Management, ISO Compliance, and Regulatory Affairs.

Ortho-Technology, Inc. – September 2003 to September 2006, Tampa FL

DIRECTOR OF OPERATIONS for this distributor of orthodontic medical devices and supplies. Areas of responsibility include: Distribution, Purchasing, Information Systems, and Quality Systems/Regulatory Affairs including FDA, EU, and Canadian regulatory bodies.

Reptron Manufacturing Services, Inc. – September 2000 to September 2003, Tampa FL

QUALITY MANAGER for this contract electronics manufacturer. Responsible for: Customer program quality engineering; Incoming, in process, and final inspection; Document control; Supplier quality; ISO 9000 certification and maintenance. Additional responsibilities included training employees in statistical techniques and managing Six Sigma projects.

Celotex Corporation – March 1999 to May 2000, St. Petersburg, FL

OPERATIONAL EXCELLENCE PROGRAM MANAGER in the Gypsum products business unit for this manufacturer of building products. Achieved and sustained the highest level of Six Sigma program savings out of four business units.

Bescast, Inc – July 1996 to January 1999, Willoughby, OH

MATERIALS MANAGER for this supplier of investment castings to the aerospace/defense, gas turbine, and gas compressor industries. Implemented a new ERP system to support inventory management, purchasing, and production control responsibilities.

Stephan Klamic – (page 2)

BACKGROUND AND SKILLS (cont.)

CONSULTING

Independent Consultant – March 1991 to July, 1996, Cleveland, OH

Consulting services for small and mid-sized companies. Practice areas included:

· Design and implementation of quality management systems;

· Selection and implementation of business management systems; and,

· Business process re-engineering.

Price Waterhouse - July 1989 to March 1991, Cleveland, OH

SENIOR CONSULTANT in Middle Market and Growing Business consulting practice. Consulted in manufacturing operations, quality management, and workout/turnaround situations.

Cimcorp, Inc. - March 1987 to June 1989, Dearborn, MI

SENIOR MEMBER - TECHNICAL STAFF for this consulting firm. Staff member at the Ford Motor Company involved in the development and implementation of manufacturing automation projects, operations improvement programs, and quality management techniques.

A. T. Kearney, Inc. - June 1983 to March 1987, Cleveland, OH

ASSOCIATE for this management-consulting firm. Participated in numerous operations improvement assignments including manufacturing automation, organization design, and supply-chain management.

PROFESSIONAL ACCOMPLISHMENTS

· Implemented ISO 13485:2003 Medical Device Quality Management Systems.

· Response and resolution of FDA warning letters.

· Attained Six-Sigma Master Black Belt certification. Trained plant staff and line managers in Black Belt and Green Belt techniques leading to the institutionalization of a continuous improvement philosophy and improved operating results.

· Implemented several business management systems for small to mid-sized manufacturers leading to increased customer satisfaction and company profitability.

EDUCATION

B. S. - Mechanical Engineering Technology

Cleveland State University, Cleveland, Ohio

A. S. - Mechanical Engineering Technology

Lakeland Community College, Mentor, Ohio

Continuing Education programs including: Six-Sigma Master Black Belt, Financial Planning for Manufacturing Organizations, Systems Analysis, Set-up Reduction, Time and Motion Studies, and Several Supply-Chain Management System programs.

INTERESTS

Travel, Golf

EXCELLENT REFERENCES AVAILABLE UPON REQUEST

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