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Quality Manager/Director

Wheeling, Illinois, 60090, United States
May 26, 2010

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**** ******** **** *****: 847-***-****

Wheeling, IL 60090


Experienced Quality Assurance Systems Engineering Specialist with progressive levels of Q.A./Q.C. Engineering, and Supply Chain Quality in product manufacturing, assembly, process and system engineering in the aerospace/defense, military, medical device, consumer products, plastic injection, mechanical and electronics industries. Particular expertise includes compliance, technical certification, quality management systems - documentation and process improvement initiatives. Advanced knowledge of quality systems, Good Manufacturing Practices (GMPs), quality system – manufacturing process auditing and statistical process control. Certification/Skilled/Trained in the following:

ASME (all disciplines) AWS Welding Engineering MIL Standards

Supplier Partnering ISO 9001, 13485, 21CFR820, AS 9100 Regulatory Compliance

SPC Standards Problem Solving Manufacturing Engineering

QSR – GMP Standards Root Cause Analysis Calibration Control

New Product Development Design Review Quality System Auditing

Total Quality Technical Procedural Writing Material Handling

Metric-Trending Analysis Material Review Board Continuous Improvement

Time/Cost Saving Measures Failure Investigation Control Plans

ANSI & ASNT Standards Corrective/Preventive Action (CAPA) Geometric Dimensioning & Tolerancing


SRI Technologies Inc. – Nypro Chicago, Gurnee, IL 12/2008 – 1/2010

International manufacturer of plastic injection molded components and Class II Medical Devices.

Contract-Consultant: Quality Assurance Documentation Specialist – Supplier Quality Engineer

Reporting to the Quality Assurance Manager, assess the Quality Management System (QMS) to ISO and FDA Standards, and developed a gap analysis of current system.

· Rewrote the Quality Assurance Manual and quality system procedures to current industry standard requirements.

· Mitigated CAPA Program issues of a quality improvement plan with major customer.

Reporting to the Healthcare Global Business Unit Vice President of Quality & Regulatory Affairs:

· Developed and implemented a comprehensive Global Business Unit (9 plant) Purchasing Control - Supplier Quality Program in 6 weeks. Conducted Quality Management System and Manufacturing Process Audits of critical supplier operations.

Delta Pharma – Astellas Pharma US, Deerfield, IL 4/2008 – 10/2008

International development, manufacturing and marketing of pharmaceutical products.

Contract-Consultant; Quality Assurance Systems Engineering Associate

Operating under the direction of the Associate Director of Quality Assurance Systems, developed, publish, maintain and recommend solutions for continuous improvement through the development of Quality Assurance System Metrics in the areas of product complaints, assessment audits (internal/external), deviations, document & change control, risk evaluation committee (MRB) and CAPA activity. Evaluate and analyze data for the identification of adverse trends associated with US Operations.

· Assisted in the development of a corporate quality system CAPA Program and Procedure.

· Instrumental in the development and implementation of a Management Review Process of key product metrics for continuous Improvement.

Cardinal Healthcare – VIASYS Respiratory Care, Inc., Yorba Linda, CA 8/2006 – 1/2008

International ISO/CFR 820 leader in the design and manufacture of respiratory care/inhalation therapy medical device systems.

Sr. Supplier Quality Assurance Engineer

Operating independently and under general direction of the Supplier Quality Manager:

· Maintained a regional assignment of 212 suppliers for the manufacture of respiratory and inhalation therapy medical devices and equipment.

· Conduct on-site Supplier Quality Management System, Process and Product Audits in accordance with ISO 9000, ISO 13485 and 21CFR820 Standards. Administer and follow-up of corrective actions issued for effective closure. Recommend and work with suppliers in control plan development/implementation for certification status.

· Awarded Regulatory recognition for being instrumental in updating the quality management system of an acquired company to acceptable FDA requirements.

Teleflex Medical - Hudson RCI, Arlington Heights, IL 10/2004 – 1/2006

International leader in the design and manufacture of inhalation therapy and oxygen delivery medical device systems. Manufacturer of Blow-Fill-Seal Bottled Sterile Water Products.

Quality Assurance Compliance Specialist

Under the general direction of the Quality Manager, oversee and manage the internal quality system compliance program by facility auditing to current ISO, QSR, and GMP Standards. Maintain site corrective and preventive action system and lead the site’s continuous improvement efforts. Manage the Supply Chain Quality Program and conduct on-site supplier quality system audits. Member of the Material Review Board (MRB) for the disposition of non-conforming product.

· Instrumental in the development and implementation of new internal CAPA and Supplier Qualification Programs.

· Initiated 90% reduction of open corrective actions in 30 days.

· Identified and developed new method for component delivery that resulted in a 40% increase in production capacity.

· Developed and implemented a Supplier Quality Program within two months.

Shure, Inc., Wheeling, IL 6/2000 – 8/2004

International ISO Certified leader in the design, manufacture and assembly of wireless microphone and electronic audio systems.

Quality Engineer II

Reporting to the Quality Manager, responsible for all quality initiatives in a multi-product line. Duties include: trending analysis, technical review, non-conforming issues, training, problem solving techniques, material handling and safety.

· Initiated and facilitated a annual company cost saving measure of $100,000.00 of “Jiffy Bags” for Microphones.

· Identified root cause and instituted a corrective action for microphone cartridges to reduce product order backlog.

· Successfully facilitated and implemented a quality program including specifications and procedures for design engineering review of three new products. Reduced engineering changes by approximately 20%.

· Spearheaded the transition of incoming inspection instructions from Supplier Quality Assurance (SQA) to plant level quality engineering. Drove the SQA process down to the plant level thus reducing organizational delays.

· Independently developed, executed and published First Pass Yield Analysis reports of new products’ production.

· Evaluated and recommended the purchase of Shure’s first Video Capture Coordinate Measurement Machine which accelerated the incoming inspection process by 50%.

· Personally restructured and developed a plant-wide calibration, control and recall system for precision measuring and test equipment.

· Developed and administered the training and testing of associates on electrostatic discharge (ESD) and proper printed circuit board (PCB) handling and reduced in-house defects by approximately 20%.

Boston Scientific/Symbiosis Corporation, Miami, FL 3/1997 – 11/1998

Worldwide ISO Certified design, manufacture and assembly of non-invasive, disposable surgical instruments.

Senior Supplier Quality Engineer

Reporting to the Supplier Quality Manager, chaired material review board, approved and conducted quality system surveys of new and existing suppliers. Perform managerial duties in the absence of immediate supervisor.

· Improved receiving inspection backlog 58% and reduced receiving inspection priority items by 70%.

· Spearheaded and implemented shared divisional supplier on-site audits which resulted in approximately a $7,000.00 per year saving.

· Improved and reduced receiving inspection time by 20% over previous year.

· Developed and implemented Dock to Stock/Ship to Stock Program resulting in a reduction of 180 hours of receiving inspection time per month.

· Selected as a Corporate Supplier Quality Team Member for worldwide corporate quality standard development.

Telectronics Corporation, Miami, FL 11/1996 – 1/1997

World leader in the design and manufacture of Class III Implantable Medical Devices.

Procurement Quality Assurance Engineer

Reporting to the Procurement Quality Manager, duties included the procurement of components and materials, receiving inspection, discrepant material. Developed a system of processing and reducing the material backlog in receiving inspection by 30%.

EDUCATION - Course Study (Business Management) – Weber State University, Ogden, UT 1990

Course Study (Electrical Engineering) - Loyola University, New Orleans, LA 1974

PROFESSIONAL AFFILIATIONS - American Society of Quality – Current Senior Member.

MILITARY - United States Air Force - Meritoriously Honorable Discharge - Vietnam Veteran

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