Complaint Handling Specialist

Palo Alto, CA

Job ID: 119394 Industry: Quality

 

Complaint Handling Specialist

Environment:

Our client is a large Medical Device organization that develops and manufactures complex Class II Medical Imaging  Devices. They are currently in need of a Complaint Handling Specialist to support the Complaint Handling process- dealing with back-logged complaints and real-time complaints that will come in.

Responsibilities:

The Complaint Handling Specialist will be from a Medical Device background. They will be  dealing with real-time complaints as they come in, as well as closing out back-logged complaints. This individual should have a background in Complaint Handling and Complaint Investigations for Class II  Medical Devices (ideally Medical Imaging  devices). This individual should also have a strong background in Risk Management, and should be able to make recommendations for complaints based on risk levels. They will need to understand the regulatory requirements associated with complaints from OPEN TO CLOSE. The Complaint Handling Specialist should also have a strong understanding of Post-Market Surveillance and Recall background to analyze post-market data. Experience with CAPA would be a plus.

Required:
  • Medical Device: 5-8+ years
  • Complaint Handling (Open to Close): 5-8+ years
  • Complaint Investigations
  • Risk Management
  • Capital Equipment
  • Class II  Medical Devices
  • FDA Regulatory Requirements
  • Post-Market Surveillance & Recall

 
  • Plus:
  • CAPA Experience
  • Understanding  of Software & Hardware Troubleshooting

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