Jeff White Email & Phone Number

Monrovia/ Lake Forest

Process Validation and Project Management of Programs to expand and ensure manufacturing capacity.

Draper UT

Validation SME managing validation projects and leading teams for remdiating Production and Process controls. Performing gap analysis and conducting IQ, OQ, PQ and Test Method Validations.

Ann Arbor Mich (terumo)

Project management leading design updates and process remediation. Validation SME performing TMVs and remediation of processes for electro-mechanical blood pumps.

Brea

Managed plant activities for process development, validation and assembly of various Medical Devices for contract services. Developed company validation testing strategies for IQ,OQ and PQs, packaging and sterilization of Medical devices per PDP plans. Company is certified ISTA packaging test lab and contract sterilizer.Achieved 42% labor efficiency gain.

Design, Development and Manufacture of Orthopaedic surgery devices.

Plant Operations leader for the contract development and manufacture of an array of sterile, single use Medical devices supporting 35 major customers producing over 250 diverse SKUs. Oversee Production, Sustaining Engineering, Facilities, Maintenance and Safety. Plant produces $120 MM in outsourced product income translating to over $600 MM in product.

Managed Facility expansion including buildout for additional cleanroom. Re-organized and streamlined Warehouse and Production areas leading to successful ISO/FDA facility approval.Spearheaded program for company wide ERP (Expandable) software selection and successful implementation within 3 months. Implemented Kan ban (pull system) system in production and.

Irvine, CA

Bsme, Mechanical Engineering

Activities and Societies: Theta Tau Fraternity Michigan Tech Wrestling Team

Business Management Courses