Development Quality Engineer # JN -052021-64395

Menlo Park, California
Industry: Database Administrator / Engineers
Job Number: JN -052021-64395

Title                          : Development Quality Engineer

Location                   : Menlo Park, CA

Duration                  : 12 months initial contract

 

Job Description:

  • Develop and Validate test methods for evaluation of product requirements
  • Initiate, execute, and track role appropriate Design Controls quality deliverables
  • Plan and execute Product Quality Risk Management activities with the cross functional development team (Failure Modes Effects Analysis, Risk Controls/Mitigations, Verification and Validation, etc)
  • Develop and implement product and process inspection and monitoring requirements
  • Collaborate and provide guidance to cross functional R&D and Manufacturing teams to establish verification and validation strategy
  • Author and execute Design Verification, Shelf Life, and Process Validation studies protocols and reports
  • Investigate and provide guidance and input in resolving deviations and non-conformances associated with Design Verification, Shelf Life, and Process Validation studies
  • Perform and interpret appropriate data and statistical analysis of test results
  • Execute work in compliance to applicable Standards and Regulations (e.g. CFR 820, EU MDR 2017 / 745, ISO 13485, ISO 14971, etc)

 

Qualifications:

  • Bachelor's degree plus 2-5 years of related work experience with a good understanding of specified functional area, or Master's degree with 0-2 years of related work experience, or an equivalent combination of education and work experience. 
  • (Technical/Business Knowledge (Job Skills)) Working technical knowledge and application of concepts, practices and procedures. General understanding of business unit/group function. Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations.
  • (Cognitive Skills) Works on problems of moderate scope where analysis of situations or data requires a review of identifiable factors. Exercises judgment within defined procedures and practices to determine appropriate action. Has a broad knowledge of technical alternatives and an understanding of their impact on the systems environment


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