Manager Quality
Resume:
MYRON M. DUMMER, MBA
Santa Rosa, CA 95403
Phone: 507-***-**** e-mail: *******************@*****.***
ASQ Quality and Training Certifications:
ASQ-Certified Quality Engineer (CQE), ASQ-Certified Quality Manager/Op. Excellence
RABQSR Certified Lead Auditor ISO 9001/13485/14001 w/ Title 21, CFR, 820 Compliance
Lean-Six Sigma Green Belt, Sterilization-Gamma, ETO
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. Sr. Project “Optimizing
Production Flow in the PCB Department of Taytronics”
Skills:
Internal ISO 13485/9001 Quality System Auditor Trainer.
Problem Solving Trainer incorporating Ish ikawa Diagram and 5 W hy Analysis, 8D, 7-Step.
Safety Program Evaluator, Trainer, and Manager for alignment with OSHA/CAL OSHA .
W ork cell layout analysis for continual flow, 5s, Poka -Yoke, and Safety.
ESD/EOS Program Management, RoHS/REACH Program Management.
Customer Interface for quality planning, NDA’s, complaints, paper audits, site audits, CAPA.
Risk evaluation/mitigation through FMEA/Control Plan development and transitioning into
process work instruction.
Equipment qualification/Validation IQ, OQ, PQ, Calibration Management/Implementation.
Device History Records/Lot Traceab ility/Labeling to FDA-GMP, Title 21, Section 820.
Cleanroom Management per USP 797 and ISO 14644/ISO 14698 ISO Class 7/8.
IPC-A-610 Certified Trainer Train the Trainer. IPC-A-620 awareness.
Customer Complaint Investigations (Voice of the Customer), CAPA Systems/Effectiven ess.
Work Experience:
SMC Ltd., Santa Rosa, CA
Medical Device Plastic Injection Molding -Contract Manufacturer.
Quality and Safety Manager/Training Coordinator May 2011 to Present
Lead the Quality Department- Engineer, Supervisor, Quality Technicians, and Auditors ---
--11 employees for 3 shifts/5 days per week 63,000 sq. ft. facility.
Facilitator/Quality Management Rep. of the ISO 13485:2003/ISO 9001:2008. Update
and improve the Business Management System Manual and aligned the Business
Management System with the requirements of the FD A, Title 21, GMP 820.
Lead customer interactions for project meetings, audits, quality FAI, Gage R&R, CpK
Analysis, and Tours.
Instrumental in Problem Solving and Training and Root Cause Analysis using Ishikawa
Cause and Effect and 5 Why Methodology.
Implemented Cal OSHA, Injury & Illness Prevention Program and developed SMC IIPP.
Conducted monthly tailgate meetings on pertinent safety topics and facilitated the
Quarterly Safety Training on LOTO, Blood Borne Pathogens, Right -To-Know Hazard
Communication, and Proper Lifting Techniques. Developed New Employee “Orientation
to Safety” program/video.
Accumold, Inc. Ankeny, IA
Precision Plastic Injection, Small Mold/Micro-molder.
Quality Engineer (Temporary Position September 2010 to March 2011
Customer focused Quality Team Leader from mold design review through 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.
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Evaluated/purchased measurement tools for product specific critical qualit y characteristics,
i.e. Go/No Go Gage Pins, Ring Gages, digital indicators. OGP ZIP Visual Inspection System .
Material Review Board Problem Solver leading to internal and/or customer corrective action.
W orked on 5s projects for continual improvement and w aste 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
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.
Customer Complaint Management, Failure Investigation, Corrective Action, Cont. Improve.
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 Hydrogel Products, Wound Care, Printing Conductive Inks.
Director of Quality April 2008 to July 2009
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 20.
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.
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 objec tives.
Led the implementation of The Balanced Scorecard to drive strategy through the organization
Developed strategic and organizational budgets for Quality, to support 25% top-line growth.
Sourced Suppliers for PCB’s, Magnetics, and LCD’s in the People’s Republic of China,
Thailand and Taiwan. Assisted lowering costs approximately 30% while retaining quality
levels of approximately 99.8%.
Led the Quality Dept. Quality Engineers (2) Receiving Inspection and In-Process Auditors.
Implemented ISO 13485:2003 Business Management System, Management Representative
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
Reviewed and updated company wide Right -to-Know Program. IPC-A-610 “Acceptability of
Electronic Assemblies”, Certified Trainer. Led the implementation of ISO 9001:1994
Organizations:
American Society for Quality, Redwood Empire Section, 0617 Leadership, “Event Chair”.
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