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Quality Assurance Manager

Location:
Windsor, PA
Salary:
85,000
Posted:
January 15, 2014

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Resume:

Ron Reed, ASQ CQA

*** ********* *****, *** ****, PA 17356

717-***-****

acb6b8@r.postjobfree.com

Experience

Quality management; operations and research and development; engineering, quality, and

manufacturing management; process, materials, and product development and validation.

Familiar with cGMP, ISO (9001, 17020, 17025, and 13485), CFR, International Code

Council, ASTM and other national and governmental standards.

Employment History

2010 to Present Architectural Testing, Inc York, PA

2012 to … Administrator – Product Certification

2010 to 2012 Assistant Administrator – Certification Services

Manage ten quality assurance and product certification programs.

Oversee quality assurance auditing and reporting, with a staff of

18 auditors and 5 administrative personnel for standards related

to international building codes, ASTM Standards, and building

product certification programs.

Work with the Director, Product Certification, and assigned

staff to administer all aspects of product certification and

quality assurance programs.

Work with international firms on mutual recognition and

contract auditing agreements.

Continually monitor programs and operations to improve

accuracy and efficiency.

Develop, review, and recommend quality systems, procedures,

program guidelines, and manuals for clients.

Conduct quality system and plant audits for extrusion,

injection molding, metal roll forming, glass, assembly and

other manufacturing facilities.

Review audits and action item responses for accuracy and

completeness.

Train and qualify auditors.

Assist with sales and marketing efforts to promote and

develop new product certification programs.

2006 to 2009 MAX International Inc. Lancaster, Pa

Operations Manager

Operation management for rotary and flexographic printing and

slitting organization specializing in retail, security, and printing of

specialized inks and materials.

Manage 12 quality, operations, manufacturing, and

warehousing personnel and expenses.

Ron Reed, ASQ CQA

125 Woodsview Drive, Red Lion, PA 17356

717-***-****

acb6b8@r.postjobfree.com

Develop quality procedures and systems to improve product

consistency.

Develop product specifications and systems to ensure vendor

accuracy.

Develop material handling systems and processes to reduce

worker stress and increase efficiency.

Update and validate equipment with new electrical and PLC

control systems.

Increased efficiency and reduced downtime on equipment over

30%.

Develop incoming and in process quality checks and

parameters to reduce waste.

Analyze data to formulate and recommend efficiency

improvements, cost savings, and quality improvements.

Responsible for budgeting of equipment, maintenance, and

materials.

1988 to 2006 Conductive Technologies, Inc. York, Pa

1997 to 2006 Director of Medical Sensor Development and Manufacturing

1992 to 1996 Manager, Sensor Research and Development

1988 to 1992 R&D Lab Technician

Manage a group of 30 to 35 engineering, quality, and

manufacturing personnel in the development and manufacturing of

diagnostic medical sensors. Managed design, process,

manufacturing, and quality for the manufacture of electro

chemical and diagnostic sensors, flexible printed circuits, and

membrane switches.

Work within ISO 9001 system, cGMP, and client FDA and

ISO 13485 requirements.

Work closely with customers, quality department, vendors,

and manufacturing to develop specifications and quality

systems for specific programs.

Write and review standard operating procedures and process

documents.

Perform customer visits and participate in customer and

supplier quality audits and visits.

Prepare, update, and tolerance product, testing, and equipment

AutoCAD drawings and specifications.

Analyze data for nonconformance and formulate and

recommend corrective and preventative action when issues

arise.

Recommend, budget, and implement plant upgrades and work

with outsides vendors to specify, install, and validate

installations.

Work on and lead quality and Continuous Process

Improvement (CPI) Teams to identify areas for improvement

and formulate and recommend corrective actions.

Work with standard and geometric dimensioning tolerances.

Ron Reed, ASQ CQA

125 Woodsview Drive, Red Lion, PA 17356

717-***-****

acb6b8@r.postjobfree.com

Develop validation protocols, as well as IQ, OQ, and PQ plans

for validation of products, materials, and equipment.

Manage group of engineers and floor technicians.

Utilize various manual, CMM, and automated and vision

measuring systems.

Worked internally and with external companies to develop,

test, and validate raw materials for manufacturing.

Instrumental in setting up and helping new business

opportunities grow into a $16 million business unit.

Research new technologies and equipment.

Develop and validate processes and methods for designing and

manufacturing of screen printed diagnostic sensors.

Help in building specifications and a quality system to meet

the needs of FDA regulated customers.

Work closely with customers and suppliers, as well as internal

departments, to engineer designs, develop materials, and

validate systems for use in manufacturing diagnostic sensors.

Education/Certifications

American Society for Quality

Certified Quality Auditor Certification – Certified June 2013

ASQ – American Society for Quality

Master of Business Administration

Completed May, 2010

Ashford University, Clinton, IA

B.S. in Business Management

University of Phoenix B.S. program.

University of Phoenix Online, Phoenix, AZ

Associates in Specialized Technology:

Electronic Engineering Technology

Thompson Institute of Technology, Harrisburg, PA

Certificate of Completion

Understanding FDA’s Medical Device Quality System Regulations

Stat-A-Matrix Institute

Certificate of Completion

Simplified Strategic Planning

Eli Broad Graduate School of Management, Michigan State Univ.



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