Greg Paul Email & Phone Number

Gilbert Az

Retired to Gilbert Arizona. Enjoying Hiking, Biking, Traveling & Completive shooting.

San Diego, California, United States

San Diego, Ca

Senior team member contributing to the front end design facilitation, design transfer to manufacturing, and process improvements of class II FDA medical devices. Provide quality indicators and statistics to business teams for actionable process and cost improvements while supporting product reliability, safety, and regulatory effectiveness. Assures design and production are in compliance with applicable regulatory standards by overseeing test methods, equipment, validations, change orders… Show more Senior team member contributing to the front end design facilitation, design transfer to manufacturing, and process improvements of class II FDA medical devices. Provide quality indicators and statistics to business teams for actionable process and cost improvements while supporting product reliability, safety, and regulatory effectiveness. Assures design and production are in compliance with applicable regulatory standards by overseeing test methods, equipment, validations, change orders, corrective actions and verification of effectiveness. Show less

Greater San Diego Area

Provide engineering support for Infusion class II medical device business unit. Responsible for generating and closing required Quality Notifications, Quality Plans, Process Deviations, Change Orders, Risk Assessments, Inspection Plans, CAPA’s, Process Hazard Analysis, Process Validation Plans and Installation Operations Qualifications. • Responsible for FDA 21CFR 820.200 requirements to analyze part and component service trends to assignable cause. • SME for Test… Show more Provide engineering support for Infusion class II medical device business unit. Responsible for generating and closing required Quality Notifications, Quality Plans, Process Deviations, Change Orders, Risk Assessments, Inspection Plans, CAPA’s, Process Hazard Analysis, Process Validation Plans and Installation Operations Qualifications. • Responsible for FDA 21CFR 820.200 requirements to analyze part and component service trends to assignable cause. • SME for Test verification of class II medical device in Repair Center and Field Service.• Lead QE for Medical Device Recalls, Remediation plans and documentation.• Lead QE for GCS (Global Customer Support) Repair Center and Field Service teams. • Responsible to present the Service Center QBR (Quarterly Business Review) performance metrics. • Participated in Operational Excellence LMI (Lean Maturity Index) to develop a cross training plan and measurement metric.• Participated in FDA driven Risk Assessment and PHA (Process Hazard Analysis) remediation. Show less

Greater San Diego Area

Conduct compliance audits for CareFusion medical device & medical dispensing product lines as well as the Service Depot. Tasked to track and resolve identified compliance issues and generate a weekly graphical report to demonstrate effectiveness to the QMS (Quality Management System). Conduct daily cGMP audits and GDP reviews and corrected identified weaknesses. • Developed detailed audit checklists for each product line, as well as graphical reports to tack effectiveness.… Show more Conduct compliance audits for CareFusion medical device & medical dispensing product lines as well as the Service Depot. Tasked to track and resolve identified compliance issues and generate a weekly graphical report to demonstrate effectiveness to the QMS (Quality Management System). Conduct daily cGMP audits and GDP reviews and corrected identified weaknesses. • Developed detailed audit checklists for each product line, as well as graphical reports to tack effectiveness. Validated the fore mention checklists and spreadsheets. Show less

San Jose

Responsible for product feasibility, quality, and performance as well as design compatibility for Komag’s thin film media products sold into all IBM Fujisawa and IBM San Jose HDD (Hard Disk Drive) product lines. Collaborated daily with the US based NPI and Asian offshore low cost manufacturing teams to identify and resolve product issues. Identified technology roadblocks and provided solution paths related to customer program qualifications and advanced products. • Developed data driven… Show more Responsible for product feasibility, quality, and performance as well as design compatibility for Komag’s thin film media products sold into all IBM Fujisawa and IBM San Jose HDD (Hard Disk Drive) product lines. Collaborated daily with the US based NPI and Asian offshore low cost manufacturing teams to identify and resolve product issues. Identified technology roadblocks and provided solution paths related to customer program qualifications and advanced products. • Developed data driven qualification strategies.• Managed MRR (Manufacturing Readiness Review) for successful program launch as well as disseminated the information to the Asian manufacturing facility.Facilitated problem solving teams for continuous improve of sustaining products throughout their life cycle. Show less

San Jose

Managed the ISO9001 certified Test Department which provided 24x7 support for Sourcing outgoing product quality of thin film recording media for the HDD industry. Test Lab consisted of 18 Engineers, Technician’s & Operators responsible to provide customer test correlation, test standards, first articles, product samples and customer graphical datapackages for weekly ship-to-stock product requirements. The Lab hosted internal customer visits for product qualifications, test validations, test… Show more Managed the ISO9001 certified Test Department which provided 24x7 support for Sourcing outgoing product quality of thin film recording media for the HDD industry. Test Lab consisted of 18 Engineers, Technician’s & Operators responsible to provide customer test correlation, test standards, first articles, product samples and customer graphical datapackages for weekly ship-to-stock product requirements. The Lab hosted internal customer visits for product qualifications, test validations, test gage R&R and product failure investigations. • Successfully managed the lab from inception to closure. Purchased over $10M in capital test equipment. In 1996 the lab achieved ISO9001 certification. • Responsible for customer driven product yield improvement teams, RMA failure analysis as well as implemented customer driven changes to the out going quality tests and sampling plans.• Developed and implement departmental software control procedures, SPC Six Sigma test plans, and Gage R&R studies.• Directed automated software development for graphical data providing reliable turnkey reports while reducing cost.• Implemented sampled test strategy, based on pattern recognition, to predict yield performance in the customer’s HDD.• Assumed a role as Internal ISO9001 prep-Auditor to assist manufacturing in achieving their ISO9001 qualification. Show less

Phoenix, Arizona Area

Responsibilities included environmental testing and associated yield tracking of ceramic heat sinks supplied to the telecommunications industry. Performed product test qualifications and validations for temperature, humidity, altitude environmental shock, shear, hardness, and tensile testing. Generated product specifications as well as analyzed and reported on Customer RMA failures.

Tempe Arizona

Responsible for hardware and software maintenance, as well as product test configurations of Schlumberger Series 80 mixed signal test systems, Electroglas 2001 & 1024 wafer probers, Sentry 7, STS, and LTX wafer test systems. Proficient in using oscilloscopes, spectrum analyzers, and waveform generators. Monitored the Test Floor capacity and testing throughput for improvement opportunities and constraints. • Key contributor of the Test Confidence Team focused on continuous improvement for… Show more Responsible for hardware and software maintenance, as well as product test configurations of Schlumberger Series 80 mixed signal test systems, Electroglas 2001 & 1024 wafer probers, Sentry 7, STS, and LTX wafer test systems. Proficient in using oscilloscopes, spectrum analyzers, and waveform generators. Monitored the Test Floor capacity and testing throughput for improvement opportunities and constraints. • Key contributor of the Test Confidence Team focused on continuous improvement for cGMP & GLP for medical device lab.• Participated in generating an FDA audit and training specification. Show less

Tempe Arizona

Responsible for logistics, maintenance, and processes related to Final Test Department for HDD media manufacturing. Liaison between Quality, MIS, Production, and Suppliers for the Manufacturing Test Equipment Department. Managed statistical control for Final Test area, generating test standards, control charts, correlation, and capability studies for six-sigma process and test control. Developed test set-ups, calibration specifications, operating procedures for equipment and processes at… Show more Responsible for logistics, maintenance, and processes related to Final Test Department for HDD media manufacturing. Liaison between Quality, MIS, Production, and Suppliers for the Manufacturing Test Equipment Department. Managed statistical control for Final Test area, generating test standards, control charts, correlation, and capability studies for six-sigma process and test control. Developed test set-ups, calibration specifications, operating procedures for equipment and processes at Manufacturing Final Test. Identified and communicated software/hardware bugs to test equipment suppliers and executed test equipment upgrades. Show less

Sidney Ohio

Responsible for 200mm and 130mm HDD product troubleshooting at Final Test with extensive theory and troubleshooting experience in utilizing a wide variety of thin film media test equipment. Participated in Stolle’s HDD start-up operation. Responsible for the 130mm disk stiction, friction, reliability and durability test equipment, test results and data reporting.

B.S. Business Information Systems, Computer Science

Eet (Electrical Engineering Technology)

Cqe (Certified Quality Engineer) Refresher Course