Quality Engineer :19-02326

Sunnyvale, CA 94086

Posted: 05/24/2019 Job Category: Technician - Laboratory, Manufacturing, Electronics, Electrical Job Number: 12222149
     Women Back to Work (WBW) candidates will also be considered for this position.

Akraya is looking for a Quality Engineer.To be considered, please apply or call Moiz at 408-816-2442If this position is not quite what you’re looking for, visit akraya.com and submit a copy of your resume. We will get to work finding you a job that is a better match at one of our many amazing clients.
Primary Skills:  Failure Analysis, quality engineering, medical device,  Six Sigma
Duration: 6+ Months (possible extension)
Tax Term : W2 Only   
 This position has responsibility and authority for:
  • 75% failure investigation, 25% quality advocacy and project management.
  • Quality Advocacy and Project Management.
  • Apply corporate level quality metrics.
  • Lead quality initiatives in one or more of these focus areas:
    • Product Quality, Data Quality, Process Quality
  • Failure Analysis
    • Perform deep technical failure analysis based on the physics of failure.
    • Reviews and trends product and process quality issues using data analysis and root cause investigation.
    • Perform risk analysis and determines quality disposition for variance requests and non-conformances.
  • Represents the department cross-functionally in meetings that may include senior and external personnel.
  • Review process and document changes through engineering change orders and deviations using client's change control process.
  • Escalates to direct management all quality issues that could impact patient safety or surgical efficacy.
  • Ensures successful, on-time completion of department projects, communicates constraints to direct management when successful project completion is at risk.
  • Performs other duties as assigned by management.
  • Education: Bachelor degree in electrical, mechanical, biomedical or system engineering, math, or physics. Advanced degree preferred.
  • Minimum 1 plus years of working experience, preferable in medical device manufacturing environment.
  • Demonstrated Understanding of CFR 21 820/ ISO 13485 in a nice to have
  • Understands product risks & FMEA.
  • Understand mechanical complex problems with minimal oversight.
  • Understanding of SPC & Six Sigma methodology and tools (e.g. uses DMAIC process and basic tools such as 5 Why's, control charts, fishbone diagram).
  • Able to create Multi-source report, trends, and interprets data with minimal oversight.
 Please apply directly with your update resume or call Moiz at 408-816-2442

About Akraya
Akraya, Inc. is an award-winning staffing firm that works with many of the leading, technology-based companies around the world. We have been ranked as one of the “Best Staffing Firms to Temp for” by Staffing Industry Analysts on multiple occasions and are a preferred staffing vendor within numerous staffing programs. Please visit akraya.com to search through all of our current openings or to submit your resume to our recruiting team.

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