Medical Device Quality Engineer (Validation)

Boston, MA

Job ID: 127621 Industry: Med

 

Medical Device Quality Engineer (Validation)

Environment:

Our client is a large medical device manufacturer. They develop and manufacture a number of  medical devices. They recently acquired a small Biologics company and they are looking for a quality engineer to come in and support an effort where multiple 510K approved products will be converted to the PMA phase. The team will be steered by a lead who is well-versed in validation but will need extra hands to support gap assessments and then execution. 

Scope of Work:

Our client seeks a Quality Engineer to help with moving several products from the 510K phase to the PMA phase of approval. This person will be tasked with performing a variety of validation activity, including Test Method Validation, Process Validation, Risk File Reviews and Gap Assessments. They will first be tasked with performing gap assessments to guide the team as to where they need to re-validate. They will also support the project with reviews and submission of change controls, writing reports, etc. This should be someone who is very comfortable with a deep diving/ review & approve type role to start and then a transition into execution of new validation procedures. The client seeks someone hands on, who can communicate effectively with the team and report findings/updates back to management.

Required Experience:
  • Medical Device: 5-7 plus years
  • Quality Engineering
  • Validation Gap Assessment experience
  • ISO 13485

Desired:
  • MDSAP experience
  • Artifical Skin/Tissue

Job Type: Contract

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