Medical Device Risk Management SME

Los Angeles, CA

Job ID: 126621 Industry: Med

 

Medical Device Risk Management SME

Environment:
Our client is a worldwide health care company and they are in need of a Quality Engineer to support a Risk Management Remediation.

Project Scope &  Responsibilities:

This consultant will be joining an ongoing remediation project, and this consultant will be the SME for Risk Management. Our client has identified Management Files that must be remediated, and this individual will oversee this process. This person will be expected to drive cross-functional cooperation and communication  between  QA, RA, R&D, Medical Affairs and Manufacturing in order to effectively pull the correct Risk Management documentation from each department. They are looking for someone who can look at risk situations and be able to provide a solution in response to the FDA.  This will be someone with great communication skills who can interface with cross functional teams. The consultant  should have remediation experience in a quality or compliance function and have knowledge of Medical Device  QS and Risk Management requirements.

Required:
  • Medical Device Experience 10 years
  • Risk Management Experience 10 years
  • Remediation Experience

Job Type: Contract   

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