QA/RA Consultant
KetryxBoston, Massachusetts, United States
Posted September 8, 2025
130000 - 150000 USD year
Full Time
About the Company
Ketryx is a leading provider of AI-powered compliance solutions for life science teams. Their Connected Lifecycle Management platform automates documentation, enhances traceability, and accelerates product release cycles without disrupting existing workflows. By leveraging AI Agents, Ketryx reduces manual work by 90 percent, ensuring faster and higher quality products across the entire lifecycle.
Job Description
Ketryx is seeking a QA/RA Consultant to lead quality management system implementations and regulatory compliance strategies for cutting-edge medical device clients. The role involves shaping the future of regulatory affairs through innovative technology, working with high-growth clients, and ensuring the highest quality standards. This is a rare opportunity to contribute to a mission-driven company focused on improving 100 million patient lives.
Requirements
- Lead Quality Management System (QMS) setup and deployment for medical device clients
- Own and manage QMS templates and regulatory compliance frameworks
- Provide expert consulting on ISO 13485, MDSAP, GxP, and other quality systems standards
- Scale operations to support high-growth clients
- Develop repeatable QMS deployment processes leveraging AI platform capabilities and automatic compliance
- Shape the future of regulatory affairs through innovative product development
- Work independently on complex quality assurance projects requiring minimal oversight
Benefits
- Competitive compensation
- Generous stock options
- Work in an exciting field
- Opportunity to learn and grow
- Hybrid work model
- Generous PTO
