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Quality Engineer
Ref No.: 18-51612
Location: fremont, California
Position Type:Full Time/Contract
Experience Level: 6 Years
Start Date: 07/23/2018
 
Job Title Quality Engineer
Relevant Experience
(in Yrs)
4-6 Year
Technical/Functional Skills
  • 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.
Experience Required 4-6 Years