Quality Consultant

Job Summary

To support a client in need of reviewer support for quality and documentation remediation activities, the part-time Quality Consultant will work remotely for approximately 12 months, collaborating closely with Design Control and Complaint Handling while leveraging recent FDA experience.

Key responsibilities

• Provide reviewer support for quality and documentation remediation activities
• Collaborate with Design Control and Complaint Handling teams to ensure compliance
• Contribute insights from recent FDA inspections and assist with FDA 483 responses

Required qualifications

• Recent experience working with the FDA, particularly in design controls and risk management
• Strong background in validation and verification processes
• Experience contributing to FDA inspection processes and responses
• Ability to maintain a dedicated remote workspace with reliable internet access
• Understanding of internal FDA processes and expectations