David L. Kuhns
540 67th Avenue North East, Fridley, MN 55432
Phone: 612-571-5958 fax: 612-572-1745
e-mail: e4e5@MNinter.net
Career Objective:
A Professional Quality opportunity where QUALITY is not only talked, but also walked. Where the
management philosophy and practice is customer driven. Where statistical expertise and a sound quality
understanding are utilized to its fullest potential.
Profile:
A cross functional team player who understands the people who know their own processes. A creative
problem solver who listens to the innovations expressed by the team members, and can assist those members
in the productive development of their ideas. A skilled craftsman in designing, implementing, and
analyzing statistical proof of process improvement, validation, and evidence of effectiveness.
Career Accomplishments:
- Played a key role in developing sound quality systems to comply with ISO-9001.
As a result the division achieved the C.E. mark and received the best results of the ISO
audit within the corporation.
- Successfully applied statistical queueing theory to a randomly interruptable manufacturing
process saving the company $250,000 annually in labor costs and in excess of $1,000,000 in
one time equipment (work station) acquisitions. Received the "President's Award" for this
effort.
- Implemented a complete supplier certification program including: Just in time (JIT), dock
to stock, supplier validation and qualification, certification, auditing to ISO9000, Medical
Device Directive (MDD) and Good Manufacturing Practices (GMP) requirements.
- Applied Design of Experiments to a fluidized bed process utilizing a factorial design nested
within a mixture model in order to resolve a difficulty in pharmaceutical taste masking and
manufacturability. To the knowledge of the company and the customer this was the first time
that this process was successfully used in this type of application.
- Headed a wide-ranging corporate team to comply with and achieve the Ford Q-101 rating. This
was in a plastics molding facility and accomplished before Ford Plastics Products Division
won the same award.
Publications:
- Statistical Tools for Process Control, A Workshop
- The Application of Queueing Theory to Manufacturing Processes.
- A Practical Approach to Design of Experiments, Merging the Traditional with the Modern.
Professional Experience:
- Continuous Quality support of manufacturing.
- Prospective and retrospective validation of manufacturing processes.
- Validation of the construction of a GMP facility.
- Design of Experiments for clinical studies, manufacturing process improvement, optimization
and validation.
- Investigation of government and private statistical findings, demonstrating inconsistencies
in analysis.
- Taught more than 2000 people in Statistical Process Control, Team Problem Solving, and Design
of Experiments.
- President, Minnesota State Chess Association (500 members).
Education and professional development:
- Bachelor of Statistics, University of Minnesota, Institute of Technology, 1985
- Bachelor of Mathematics, University of Minnesota, Institute of Technology, 1973
- Member, American Society for Quality (ASQ)
- ASQ Certified Quality Engineer, 1989
- Member, American Statistical Association (ASA)
- Certified National Tournament Director, United States Chess Federation
Employment history:
- Manpower Technical - Medtronics Current
Senior Materials Quality Engineer, Temporary Assignment
- SIMS Deltec, St. Paul, MN 1996 - 97
Senior Materials Quality Engineer, (Reorganization layoffs)
Supplier quality and concerns, quality audits based on ISO, MDD and GMP requirements.
Incoming inspection, validations, qualifications. Supplier negotiations for pricing,
conformance to requirements, supplier certification, inspection plans and statistical analysis.
- B. Braun Medical, Mpls, MN 1995 - 96
Quality Engineer and Statistician, (Facility closed)
Key role in implementing ISO 9001. Validation of complete medical device processes including
PTA Balloon Catheters, Introducers, and other cardiovascular surgical devices. Retrospective
validations of manufacturing process and continuous quality support of medical device
manufacturing.
- CIMA Labs Inc., MN 1994 - 95
Validations Engineer and Statistician, (Start-up venture, mass layoff due to customer cutbacks)
Validation of OTC drug manufacturing processing, including fluidized bed granulation and
overcoating processes, tablet formulation, taste masking, blending, tableting and packaging.
Construction of a GMP facility and validating the systems of that construction. Assisted
Research and Development with design of experiments for taste masking and evaluation.
- Minntech Corporation, Mpls., MN 1992 - 93
Corporate Statistician and Quality Assurance Engineer, (Mass layoff due to problems with FDA)
Implementation of systems to comply with FDA GMP regulations and ISO 9001 standards. Manufacture
of cold sterilants for medical device reuse such as Dialysis filters and catheters; the automated
electronic equipment for their use; high flux dialysis filters, hemofilters and concentrators;
oxygenators and heat exchangers for cardiovascular surgery. Responsibilities included the design
and analysis of clinical studies; investigation of reported statistical findings; and quality
engineering of the fiber products.
- Product Design and Engineering, Mpls, MN 1990 - 92
Quality Assurance Manager, (Facility closed)
Implementation of a complete quality and documentation system. Taught SPC, Team Oriented Problem
Solving, and Designed Experiments. Injection Molding.
- UFE, Inc., Stillwater, MN 1986 - 89
Corporate Quality Engineer, (SPC Facilitator in 4 locations)
Implementation of SPC on a corporate scale with 'dotted line' supervision to the plant
facilitators. Taught SPC to 100% of the employees. Revised and rewrote the Quality Assurance
manuals. Achieved the Ford Q-101 rating for the company. Custom injection molding and assembly.
- Control Data Corporation, Magnetic Peripherals Division, Bloomington, MN 1979 - 86
Senior Industrial Engineer, SPC Facilitator
Implementation of SPC, taught 100% of the employees SPC in the facility (450+). Electronics,
computer disk drive assembly. Validated a 9000 square foot class 10 - 100 clean room.
President's Award for cost reduction. Control Data laid off approximately 12000 employees in
1985 - 86.
