Quality Consultant
Posted yesterday
virtual vocationsDenver (CO)
Quality Control AnalystsOther Management Consulting Services
SENIORITY
Senior
About the role
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
Before you apply
Applying takes about a minute. These four things decide how fast it moves after that.
Your profile is current
It's what we read first. Occupations, seniority and locations matter more than a long history.
Two examples you can talk through
Not a portfolio — just two pieces of work where you can explain the decisions and what you'd change.
A number in mind
What you're on now and what would make you move. We negotiate better when we know both.
Your notice period
Employers plan around it, and it's the question that stalls offers most often.
Once you apply, someone reads it and calls you before anything reaches the employer — usually within two working days.
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