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Quality Engineer
Ref No.: 18-63376
Location: Fremont, California
Position Type:Full Time/Contract
Start Date: 08/30/2018
Position : Quality Engineer
Location : Fremont, CA,
Duration : Full Time-Only Green Card OR US CITIZEN

Experience Required

Support non-conformance activities
Support CAPA activities for their closure
Work and review incoming inspection report
Support and provide guidance on Validations
Support protocol and Technical reports
Quality reviews for documentation
Audit Preparation and Support
Project Management support as needed
Creation of Quality Plans
Execution of Quality Plan Deliverables

Following skillset is a must

1. Company (Non-conformances) and NCMRs (Nonconforming Material Report)
2. Process qualifications support as a quality Engineer, support and provide guidance on Validations
3. Test method validations.
4. Authoring protocols, reviewing change orders, and customer complaint investigations
5. Candidates will also need to have a strong risk management background (ISO 13485, 14971)
6. Experience in data analysis, write statistical analysis reports
7. Creation of Quality Plans, Execution of Quality Plan Deliverables

•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