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Quality Engineer
Ref No.: 18-00272
Location: Fremont, California
Position Type:Full Time/Contract
Start Date: 03/08/2018
Job Title Quality Engineer
Relevant Experience
(in Yrs)
5-6 Year in Medical Industry or regulated industry
Technical/Functional Skills
  • Quality Engineering working knowledge and Quality Management Experience
  • working knowledge of ISO, MDD, FDA QSR 21 CFR 820 / ISO 13485 quality system requirements and the ability to provide an expert knowledge of both regulatory requirements and other compliance areas to minimize risk across product lines
  • Strong working knowledge of ISO 14971 Risk Management Process (System Risk Analysis, DFMEA/FMEA and other Risk Management tools)
  • Plant quality Engineering experience. Nonconformance, CAPA experience is must
  • Working knowledge of Microsoft office products (MS Word, Excel) and Statistical Analysis Software tools
  • Validation activities, writing protocols and reports. Validation execution
  • Engineering change order
  • Development of a Standard Procedure (SP), related Work Instructions (WI), Forms, Checklists for design verification and validation activities
Experience Required 5-6 Medical Industry or regulated industry experience
Roles & Responsibilities
  • Support non-conformance activities for their resolution
  • Support CAPA activities for their closure
  • Work and review incoming inspection report
  • Support protocol and Technical reports
  • Quality reviews for documentation
  • Audit Preparation and Support
  • Interact with stakeholders for review and alignment
  • Project Management support as needed
  • support and provide guidance on Validations
  • Creation of Quality Plans
  • Execution of Quality Plan Deliverables
Generic Managerial Skills
Education Mechanical/Bio-medical Engineering
Preferred Education: Master's Degree