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Design Assurance Quality Engineer II

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Our client is an incredible start-up that has a very disruptive technology that decreases an industry challenge with blood clotting by 98%.  They are in a new growth phase with significant new product development in their pipeline and we are supporting the Head of Quality for multiple opportunities including a Design Assurance Quality Engineer II opportunity that will help support product development projects throughout all phases of design controls (Concept to Launch), with additional responsibility for post-market surveillance activities.  Our client has had 5 new 510 (k) submissions approved by the FDA and there is exciting growth on the horizon.  Every new hire comes in with stock/equity, as well.

The Right Talent:

BS in Engineering or relevant field. 

3+ Years of Medical Device, Pharma, or Biotech Design Quality Experience.

Working knowledge of 21 CFR 820 and ISO 14971:2019.

Working knowledge of data analysis methods, including basic statistics, preferably using Minitab or other similar data analysis software.

Works well in start-up environment.

 

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