Sr. QE (Capitol EE)

San Jose  ‐ Onsite
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Description

As core team member on development projects, perform or contribute to the development of the following:
  • Quality Plans (product and supplier)
  • QFD's
  • Risk Management Plans and Reports
  • Risk Assessments including Hazard Analyses and Risk Analyses
  • Fault Tree Analysis/FMEA's (Design, Application, and Process)
  • Design Verification and Validation strategies and acceptance criteria
  • Test method development and validation
  • Risk based sampling plans
  • First Article Inspection's and Reports
  • Process Validations/Capability Analyses
  • Post Market Surveillance Reports

  • Ensure completeness of project documentation (e.g., DHF).
  • Collaborate with plant QA on NPD projects, ensuring quality deliverables have been met.
  • Ensure all tasks are conducted in accordance with applicable regulatory standards and standard operating procedures.
  • Other duties as assigned with or without accommodation.

    • Knowledge of Good Manufacturing Practices (GMP) and applicable Quality System Standards.
    • Working knowledge of FDA QSR, ISO 13485 and Medical Device Directive in regards to design controls and product realization.
    • Ability to apply tools (Six Sigma, Statistical Techniques, Sampling Principles, Risk Assessment, Root Cause Analysis, FMEA, FTA, DOE, etc.).
    • Ability to interpret mechanical drawings.


    To find out more about Real Staffing please visit www.realstaffing.com
    Start date
    01/2013
    From
    Real Staffing
    Published at
    15.12.2012
    Project ID:
    462295
    Contract type
    Permanent
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