Medical Device Quality Investigations SME

Miami, FL

Industry: Med Job Number: 123374


Medical Device Quality Investigations SME

Environment:  Our client is a large medical device manufacturer that develops a number of Class III Ventricular Assist Devices (VAD). They are currently in need of a Quality Investigations SME to support Failure Analysis Investigations, and CAPA & Complaint Investigations.

Responsibilities: The client is currently in the midst of an on-going remediation project stemming from an FDA Warning Letter. The client is in need of a strong Quality Investigations SME with a background in Mechanical or Electrical Engineering, Failure Analysis (FMEA), CAPA & Complaint Investigations. This individual will conduct these Failure Analysis investigations and Root Cause Analysis to determine the severity of mechanical component(s) failures. The consultant will also be responsible for writing Failure Analysis Investigation Reports once the investigations are complete.

Required Skills:
  • Medical Devices: 5-8+ years
  • Quality Investigations: 5-8+ years
  • Failure Analysis (FMEA)
  • CAPA
  • Complaint Handling

  • Cardiac/VAD Devices
  • Remediation Experience

Job Type: Contract  

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