Quality Engineer

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Quality Engineer

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  • Title:

    Quality Engineer
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  • Assignment Type:

    Direct Hire
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Our client located in Charlton,Ma is looking for a Quality Engineer to join their 2nd shift. This is a Direct Hire Opportunity with full benefits. 


The Lead Senior Quality Engineer is responsible for leading and mentoring team members in:

  • Using measurement equipment to measure the dimensions of the product
  • Visual inspections
  • Incoming Inspections
  • Understanding and use of ERP system (iQMS)
  • Understanding and use of ISO procedures as they relate to Quality function
  • Compiling, analyzing, and interpreting inspection data
  • Leading other projects and duties


Other Responsibilities:

  • Performs root cause analysis and implements preventive and corrective actions
  • Performs test and validation activities
  • Developing and conducting process validation (IQ, OQ and PQ)
  • Performing capability studies



  • Experience leading teams
  • Experience within the medical device industry
  • Experience working within an ISO 13485 quality system
  • Experience with performing quality audits
  • Experience with Statistical Process Control (SPC), Design of Experiment (D.O.E.), High, Low, Nominal measurements
  • Experience with all aspects regarding capability studies
  • Experience developing quality and risk documentation (Process Flow Charts, FMEAs, Control Plans, Work Instructions, etc.)
  • Gage R&R
  • Knowledge of reading and interpreting specification drawings. Knowledge of GD&T is preferred.
  • Experience working within an injection molding environment
  • Willing to do what it takes to get the job done right
  • Clearly communicates in English, both written and spoken
  • Detail oriented
  • Able to make good decisions based on facts
  • Elf Vision System experience preferred
  • Preferred ability to run Coordinate Measuring Machine (CMM) for inspections
  • FDA Regulatory experience a plus

More Info


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