Quality Management

Summary

Quality Management professional, with a wide array of experience in leadership, process controls product validation, and management of corrective action. I have spent considerable time managing and developing statistical methods to control requirement validation. My knowledge of vender and subcontract quality management gives me unique insight into building suppliers up to the level of excellence needed for a successful partnership. Experience in all phases of process mapping and continuous improvement, following ISO 13485, 9001, AS9100, and CMMI level 5 development processes. Expert in lifecycle quality management, risk based, MDP, and compliance audits which allows me to bring efficiency to the forefront of your organization.

Proficiencies and Focus Areas

Leadership

Problem solving

Project management

Customer Management

Process Mapping and Continuous Improvement

Program Metrics & Process Improvements

Certified to ISO 13485, and ISO 9001

Quality Test Management

AS9100

Compliance Inspections & Audits

NASA Compliance standards

Risk based Auditing

Mission Diagnostic Protocol Auditing

Statistical analysis

Full Software Lifecycle Quality Management

Third Party Software Asset Management

Factory oversight

Risk and Opportunity Management

Team Center, Clear Quest, and Master Control

Defect trends

ITAR

Export control

Honorable discharge from the U.S. Navy

Six Sigma

EXPERIENCE

9/14- Present Principle Quality Engineer

West Pharmaceuticals, Tempe, AZ

Quality Engineer managing harmonization of global quality system. Combining eight separate medical device manufacturing plants quality systems into one global system. Using Lean Six Sigma techniques to Value Stream map each process defining the most efficient process for companywide standardization.

Maintaining Quality and Regulator oversight for design, development, and validation for multiple contracts.

Preforming ISO 13485 internal audits, and organizing audit defense strategy through development of a culture of quality.

Validation of new Optical Metrology equipment. Worked to procure, test, define process, and validate the measurement system.

Developing in partnership with the supply chain department a process to measure and manage suppliers. Aligning Quality and purchasing data to measure suppliers for future contracts with a goal of reducing supplier defects.

10/08-09/14 Quality Assurance Lead

SGSS, General Dynamics C4S, Scottsdale, AZ

Lead the Test Quality Assurance group ensuring compliance to customer requirements regarding quality and efficiency of cutting edge ground station communications system including: customer witnessed testing, systems and software test oversight, and factory tests.

Performed project monitoring activities such as: contractual, ISO 9001, third party software, and policy compliance audits. Analysis and monitoring of project metrics for reporting in project reviews and continuous improvement activities.

Developed new audit program to ensure compliance to Third Party Software licenses requirements in complex VM environments.

Responsible for monitoring, auditing, and performance improvement certifying all software and hardware meet ISO 9001, AS9100, CMMI level 5 and stringent NASA standards

Managed four major government subcontracts, and seven small business subcontracts. Ensuring $30,000,000 of effort is completed to the requirements of the contract.

Mentored small business in implementation of ISO 9001, CMMI, and NASA requirements. Allowing them to grow from no quality management system to ISO 9001 compliance within a two year period

Directed, and conducted onsite, remote audits, Gap analysis, and provided onsite development of Quality Management Systems.

Performed statistical process improvement analysis leading to development of a new software lifecycle concept which reduced cost of defects by 25% and allowed for 30% improvement in customer satisfaction.

Performed statistical process improvement analysis leading to 40% improvement in document release cycle time.

11/01 - 10/08 Lab Manager/Systems Defect Manager

General Dynamics C4S, Scottsdale, AZ

Managed installation, configuration, maintenance, trouble shooting and repair of all hardware among six software development, systems testing, and engineering labs. Ensuring correct documentation of all configuration processes, and troubleshooting procedures

Lead 3 technicians in operation of over $10,000,000 in hardware.

Developed Systems triage team; training, developing, and mentoring a team of 30 Engineers in fast and effective repair of a national communications system. Managing failure review boards, customer communications during failures, and developing effective workarounds to problems.

Technical liaison to subcontractors and other departments (i.e. operations, production, and customers) regarding installation, configuration, maintenance, and repair

Troubleshoot potential hardware problems

Responsible for Radio frequency alignment, testing, and troubleshooting Hi-Rel modules for payload receivers

Maintained appropriate calibration of all hardware

05/93 - 09/01 Electronics Technician

FCTCPAC, U.S. Navy, San Diego, CA

Supervised the operation, maintenance, and repair of UHF, HF, communications suite

Supervised, trained, and mentored more than 30 technicians involving correct operation methodology, maintenance and repair of over 98 HF LOS transceivers, 7 UHF Satcom transceivers, 12 HF transmitters, 30 HF receivers, and a complex prototype retransmit system

Managed overhaul of aircraft carrier simulator. Tested, troubleshot, performed detailed design changes, and documented ten communications systems, improving efficiency by 40%.

EDUCATION

May 2012 Bachelor of Science in Business Management

Grantham University

Kansas City, Missouri

April 1998 Naval Advance Electronics program

Great Lakes Illinois

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