Medical Device Quality Engineer (DHF)

Boston, MA

Industry: Medical Device Job Number: 131235

Medical Device Quality Engineer (DHF)

Environment:

Our client is a large medical device manufacturer that develops a number of Class II & III medical devices. They are currently in need of a  Quality Engineer to come in and help with hands on execution of general Quality Engineering functions. The role will entail quite a bit of Risk Management, DHF, creating risk documentation and working with traceability matrices. 

Responsibilities:

The Quality Engineer will  be responsible for creating of risk management documentation, remediating DHF documentation, writing protocols, working with traceability matrices, etc. This is a hands on QE position with a large focus on DHF and Risk Management. The client was recently aquired by a larger organization and is in the process of remediating DHF files. It is also an ultrasonic device. Experience with orthopedics would be a plus. This person is expected to come in and hit the ground running with little guidance.

Required:
  • Medical Device (Class II & III)
  • Risk Management experience
  • DHF Remediation
  • PFMEA/DFMEA

Plus:
  • Orthopedics

Job Type: Contract  

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