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Quality Engineer
Ref No.: 18-63383
Location: Fremont, California
Start Date: 08/30/2018
Role: Quality Engineer
Location: Fremont, CA
Duration: Full time

Job Description

•    Working knowledge of cGMP guidelines, FDA 21 CFR Part 820/210/211, ICH guidelines
•    Writing IQ, OQ and PQ protocol and report and execution for Chamber validation using Client EMS.
•    Engineering change order
•    Development of a Standard Procedure (SP), related Work Instructions (WI), Forms, Checklists, Protocols, Reports & Templates for facilities/utilities, warehouse commissioning and qualification activity
•    Writing IQ, OQ and PQ protocol and report of computer system validation.
•    Hands on experience on validation in Medical Industry.
•    Working knowledge of cGMP guidelines, FDA 21 CFR Part 820/210/211, ICH guidelines 


Education

Mechanical/Electro Mechanical/ Bio-medical Engineering