Contract Design Control Scientist

📋 Description

• Author and maintain design controlled documentation in compliance with FDA QMSR, 21 CFR Part 11
• Translate laboratory processes, study plans, and analytical data into traceable, compliant
• Establish and maintain traceability across project documentation, linking requirements to design
• Review development reports, team resources, and software scripts to extract and synthesize
• Create onboarding and training documentation for R&D and CLIA team members, including training
• Manage documentation filing, version control, and change-control workflows within quality

🎯 Requirements

• BS or higher in a scientific discipline (molecular biology, biochemistry, genomics, or related
• 5+ years of experience producing controlled documentation in the medical device, IVD, or life
• Demonstrated experience working in a regulated environment with knowledge of FDA QMSR, 21 CFR Part
• Experience interpreting software implementations and structured data formats (JSON, XML) for
• Track record of working cross-functionally with Engineering, Product Management, Data Science

🎁 Benefits

• Competitive benefits including comprehensive medical, dental, vision, life and disability plans
• Free testing for employees and immediate family
• Fertility care benefits
• Pregnancy and baby bonding leave
• 401k benefits
• Commuter benefits