Greg Leon Email & Phone Number

Surprise, AZ, US

Andover, Massachusetts, US

Assisting in CAPA, NPI, & Design Transfer activities for Client Auris (owned by Johnson & Johnson)

I initiated and supported Reliability and Durability activities for both new product development (US and offshore) and sustaining engineering (mostly US) in the Medication Delivery (IV pumps) & Renal (Peritoneal and HemoDialysis equipment) business units.

I assisted a Client (Baxter Health Care) evaluate the Reliability of a new HemoDialysis product. Activities included developing reliability test protocols, modifying facility water supplies to provide correct inputs to equipment, training and managing Lab Staff to execute test protocols. Reporting daily and weekly results to senior management.

Monroeville, PA, US

• Provided Quality and Regulatory consulting to Client to resolve deficiencies found during regulatory compliance audits in multiple USA and Off-shore facilities. Working out of Colorado Springs, Philadelphia and Florida
• Develop protocol for legacy review of existing corporate documentation at over 20 sites worldwide and multiple quality systems for compliance issues.- Provide training to remote employees (USA and foreign based) to.

Albuquerque, NM, US

• VeraLight was a sister company to VeraLight. I provided manufacturing, engineering, and QA support for their spectroscopy based noninvasive Diabetes screening medical device. VeraLight was a start-up company with.
• Improved throughput and reduced errors in the incoming inspection and document control processes by implementing standardized workflow and documentation practices.
• Developed and implemented a major overhaul to the equipment management process including maintenance, calibration, documentation, IQ/OQ & PQ in order to meet ISO 13485, MDD & FDA GMP requirements.
• Developed and implemented an ESD mitigation program.
• Implemented a closed-loop NMR Process that integrated changes to documentation as part of the disposition of physical components.
• Reduced lead times from 16 weeks to 12 weeks and costs by 25-40% per assembled board via sourcing for PCB/PCBA.

US

I have the responsibility to set-up the entire Quality Management System and guide the company through ISO 13485, MDD and IVDD Certifications.

Developed a econometrics based lifecycle reliability model for developing new product.

Geneva, Switzerland, CH

Provided Quality support to remote design & manufacturing facilities. Completed design transfer from Plano, TX to Irvine CA facility.

Supported all areas of Hard Disk drive and PCB fabrication. Developed a 6-sigma rolled throughput model of several manufacturing lines to allow efficient use of resopurces to improve first pass yields. Provided support to Singapore facility.

Supportted all Reliability, Maintainability, Safety and Integrated Logistics Support (ILS) for the development of commercial and military aircraft control hardware.

Ms, Industrial Engineering

Ba, Psychobiology