Design Assurance Quality Engineer

Company Name:
ALKU
Environment:
Our client is a Mid - Sized medical device manufacturer that develops a number of Class II & III medical devices. They are currently in need of a Senior Design Assurance Quality Engineer to come in and help with quality engineering aspects of a new product launch of a class III diagnostic imaging device.

Responsibilities:
The client is currently looking to add a Design Assurance QE to their team in the Greater Boston area. Seeking a candidate with experience in Design Assurance/Controls, DHF's, Design Verification & Design Validation Protocols and Risk Management. This consultant must come from a very technical background and have worked with devices with both hardware and software components. Will be involved in re-establishing design and risk management documentation as well as building and maintaining specs for their traceability matrix.

Required:
Medical Device: 7-10+ years
NPD/Design QE: 7-10+ years
Design Controls
Design Verification & Validation
Class III devices (Software & Hardware)



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