1. Professional Resume G. Alexander Chompff
email: oldodgeboys@yahoo.com
Ph. 714-800-0549
SYNOPSIS
My professional background encompasses an eclectic range of disciplines in the medical device
and equipment industry. With an emphasis on ISO 9001 and ISO 13485 Quality Management
System (QMS) requirements, I’ve demonstrated strong engineering and management skills in
functional areas such as Manufacturing, Quality, Operations, and production line support.
EXPERIENCE
NOBLES MEDICAL TECHNOLOGY (NMT) Fountain Valley, CA Sep 2009 – Apr 2014
Manager, Manufacturing and Operations (also acting QE)
Nobles Medical Technology is a small medical device company that develops and
manufactures cardiovascular suture delivery catheters. My responsibilities in this ISO 9001
and ISO 13485 certified company were highly diverse and hands-on in the areas of
Manufacturing Engineering, Operations Management, and Quality Engineering support.
• Generated and implemented Manufacturing and Quality System documents and
procedures; these documents included Standard Operating Procedures (SOP),
Manufacturing Instructions (MI), CAPA’s, equipment maintenance instructions,
measuring instrument calibration procedures, and QC inspection instructions.
• Authored IQ/OQ/PQ protocols and test reports for processes utilizing equipment such
as sterile barrier sealers (pouch and tray), ovens, and prototype injection molding
machines. Performed product validations utilizing in-house equipment and personnel,
and performed validations for out-sourced services such as EO product sterilization.
• Coordinated all stages of product handling and control including purchasing, receiving,
inspection, stockroom, pilot plant manufacturing, discrepant goods, and finished goods.
• Managed multiple facets of manufacturing equipment; this included equipment
maintenance and repair, instrument calibration, and fixture verification and control.
SUTURA, Inc. Fountain Valley, CA Jan 2000 – Sep 2009
Manager, Manufacturing Engineering (also acting QE)
Sutura Inc was an ISO-9001 and ISO 13485 certified medical device company that
developed and manufactured disposable suture-based arteriotomy closure devices. Sutura
was dissolved in 2009 and the assets were acquired by Nobles Medical Technology (NMT,
shown above). My responsibilities for Sutura were similar to those shown under NMT.
• Developed and implemented a wide array of Quality System documents in support of
Manufacturing and Quality objectives.
• Developed and performed qualifications / validations on a wide variety of equipment,
production processes, and product revisions (similar to NMT).
• Managed and executed production equipment Installation Qualifications (IQ),
Operational Qualifications (OQ), Process Qualifications (PQ), maintenance, repairs,
instrument calibrations, and production fixture control.
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2. SORIN BIOMEDICAL, Inc. Irvine, CA 1993 – 1999
Quality Engineer (1997-1999), and Eqt Group Supv (1993-1997)
Sorin Biomedical produced disposable medical devices that included blood oxygenators,
heat exchangers, reservoirs, and supporting ancillary equipment and supplies. My
contributions to Sorin were twofold: I served as a Quality Engineer for three years, and as a
Supervisor for the Equipment Operations Group, also for three years. Sorin Biomedical
assets were obtained by Cobe Cardiovascular (Arvada, CO) in 1999.
• Conducted failure investigations of returned cardiopulmonary devices. Performed root
cause analysis based on clinical simulation testing and duplication of the reported
event. Generated formal written customer correspondence. Initiated Corrective and
Preventive Actions (CAPA) and continuous improvement efforts.
• Contributed to the development and execution of IQ/OQ/PQ qualifications that led to
the successful production line transfer of the Monolyth Blood Oxygenator device from
Sorin Biomedica (Italy) to Sorin Biomedical (USA).
• Supervised five skilled technicians in multiple facets of electromechanical production
equipment procurement, calibration, repair, maintenance, and documentation.
BAXTER HEALTHCARE, FENWAL DIVISION Irvine, CA 1989 – 1992
Engineer, Reliability and Quality Engineering
The Irvine branch of the Fenwal Automated Systems group developed and manufactured
blood plasmapheresis equipment and disposable tubing sets in a R&D and pilot production
plant facility. Company efforts primarily focused on peristaltic pump and centrifugal
separation technology in the pursuit of new products.
• Generated written protocols for the evaluation of pre-production blood plasma
separation equipment, rotary peristaltic pumps, and equipment transport structures.
Executed testing and published formal test reports.
• Developed electro-mechanical fixtures to perform accelerated product life testing.
BAXTER HEALTHCARE, EDWARDS LAABORATOIES Irvine, CA 1984 – 1989
Engineer, Reliability and Quality Engineering
This division of the Edwards Laboratories group produced vascular infusion pumps and
disposable tubing sets in a full R&D and manufacturing setting. The company's main
product, the AccuPro linear peristaltic pump, made early market penetration in the field of
precision healthcare infusion.
• Performed failure investigations of returned product. Performed root cause analysis
based on simulation testing and duplication of the reported failure.
• Designed and constructed fixtures for product evaluation and accelerated life testing.
HUMANA HOSPITAL Huntington Beach, CA 1983 – 1984
Surgical Orderly, Operating Room (OR)
PARKER AEROSPACE, Inc. Irvine, CA 1982 – 1983
Technician, Research and Development
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3. ACADEMIC- Aerospace Structural and Power Systems, Orange College (CA) 1978 – 1981
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