Quality Management Professional, ISO 13485, ISO 9001, Contract Medical
Resume:
MYRON M. DUMMER
Des Moines, IA 50320
Phone: 507-***-**** ................................................................e-mail: *******************@*****.***
Education:
Master of Business Administration, General, Minnesota State University, Mankato, MN
December 1999, Alternate Plan Paper: Best Practices Implementing Multi-rater Review
Bachelor of Science Degree, Cum Laude, Mankato State University, Mankato, MN
March 1996. Major: Manufacturing Engineering Technology
Skills:
ASQ-Certified Quality Engineer (CQE), Certified Quality Manager/Op. Excellence (CQM/OE)
RABQSR Certified Lead Auditor ISO 14001:2004, ISO 9001:2000, ISO 13485:2003
Equipment Qualification, Process Validation, Process FMEA, Advanced Problem Solving,
Lean Concepts, Lean-Six Sigma Green Belt Training, Gamma Sterilization Process
Work Experience:
Accumold, Inc. Ankeny, IA
A precision plastic injection micro-molder holding tolerances to ten-thousand inch (Contract Mfg.). Serving automotive, electronics, aerospace, and medical device markets.
Quality Engineer (Temporary Position) ................................................. September 2010 to present
Customer focused Quality Team Leader from mold design review through product obsolescence. Risk analysis/mitigation developed FMEA’s, Implemented Product Specific Control Plans and Work Instructions for NPI. Developed operator checks/measures for data recording/analysis/and improvements. Performed capability studies for critical dimensions.
Evaluated/purchased measurement tools for product specific critical quality characteristics, i.e. Go/No Go Gage Pins, Ring Gages, digital indicators.
Material Review Board Problem solver leading to internal and/or customer corrective action.
Worked on 5s projects for continual improvement and waste elimination, i.e. product specific gage identification, organization, and storage methods.
Extensive customer communication through e-mail, phone, and in-person during visits and audits of the Business Management System.
Trans-Lux/Fair-Play, Inc. Des Moines, IA
An Original Equipment Manufacturer specializing in LED Message Centers and Scoreboards
Quality Manager.................................................................................... October 2009 to June 2010
Directing a Quality Engineer and Quality Technician, Executive team member, Leader of Supplier Quality Management Team, Process/Product Improvement Leader.
Quality Team Leader for Scoreboard/Message Center software evaluation and testing.
Implemented comprehensive ESD/EOS control program to increase product reliability.
Chaired the Material Review Board/Developed Access Database to track Non-Conforming Material with Cost of Quality Reporting.
Customer communication and corrective action initiation for quality concerns and problems.
Katecho, Inc. Des Moines, IA
A Contract Medical Device Manufacturer specializing in Defibrillation/Pacing/TENS Electrodes, Conductive Adhesive Hydrogel Products, Wound Care, Printing Conductive Inks.
Director of Quality .......................................................................................April 2008 to July 2009
2
Directed two Quality Engineers, Lab Manager, Production Quality Manager, and Receiving Supervisor for day-to-day operations and planning. Responsible for a Quality Team of 30.
Developed Supplier Evaluation and Risk Assessment Tool for sourcing suppliers for custom commodities. Led supplier audit team for current/potential suppliers.
Management Representative for ISO 13485:2003, FDA Compliance QSR, Title 21, Code of Federal Regulation, Part 820, Good Manufacturing Practices.
Setup lines for cellular manufacturing with in-line Quality Inspection to support lean mfg. continuous product flow resulting in 20% increase in throughput.
Implementing a culture of lean sigma for problem solving and continuous improvement.
Liaison for company/customer interaction for product changes/process validations/problem solving. Problem solving discovery led to formulation changes in next generation of hydrogel.
Winland Electronics, Mankato, MN
A $35M Electronic Manufacturing Service (EMS) provider and a $3.5M OEM Environmental Controls and Sensors Company serving the industrial, consumer, medical, computer, and communication markets.
Director of Quality ........................................................................... February 2002 to August 2007
Strategic planning team member for establishing the organizations 15 strategic objectives,
Led the implementation of The Balanced Scorecard to drive strategy throughout the organization,
Developed strategic and organizational budgets for Quality, to support 25% annual top-line growth.
Sourced Suppliers for PCB’s, Magnetics, and LCD’s in the People’s Republic of China, and Taiwan. Assisted lowering costs approximately 30% while retaining quality levels of approximately 99.8%
Facilitated the update of Business Management System to ISO 9001:2000 and led the implementation team for ISO 13485:2003,
Project Team Leader for RoHS Implementation utilizing a due diligence process,
Project Manager for a Proprietary Product recall/enhancement program ending 9/2006,
Managed Return Material Technicians/Dept. for upgrades and service of Proprietary Product Line and Contract Mfg. Customer’s repairs and upgrades (RMA’s). Improved performance of RMA process using Lean Manufacturing Techniques, with savings of 25%.
Led the Quality Dept. Quality Engineers (2) Receiving Inspection and In-Process Auditors.
Quality Manager (Winland Electronics) ....................................... January 2000 to February 2002
Business Management System Rep. for ISO 9001, implemented First Pass Yield Metrics by customer/PN for PCB’s, developed job reporting in ERP system for DPMO in accordance with IPC-7912.
Quality Supervisor: (Winland Electronics) .......................................March 1997 to January 2000
Led implementation of ISO 9001:1994, developed Receiving/Receiving Inspection Module for Syteline ERP System to track supplier quality performance and on-time delivery, Reviewed and updated company wide Right-to-Know Program. IPC-A-610 “Acceptability of Electronic Assemblies”, Certified Trainer.
Professional Affiliations:
American Society for Quality (ASQ), Senior Member-1995 to present
Minnesota Quality Award Evaluator (Baldrige Criteria), 2002-2007
Mankato Area Council for Quality Board of Directors, Oct. 1998 to 2001
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