Ketryx · 2 days ago
AI Native QA/RA Lead
Boston, MA
Full-time
Hybrid
Senior Level
$130K/yr - $150K/yr
5+ years expKetryx is a company focused on making medical software safe and reliable, seeking an AI Native QA/RA Lead to lead quality management system implementations and regulatory compliance strategies for medical device clients. The role involves driving QMS deployment processes and ensuring high-quality standards for life-saving medical devices using innovative AI technology.
Artificial Intelligence (AI)Business Process Automation (BPA)ComplianceSaaSSoftware
No H1B
Responsibilities
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 standardsScale 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
Ensure customer success across entire the entire customer engagement lifecycle
Qualification
Required
4-8 years of experience in quality systems management, management representative or senior specialist role
Familiar with eQMS implementation, validation and implementation
Deep expertise in Quality Management System setup, sub-systems, and implementation
Strong knowledge of ISO 13485 and Global QMS requirements
Expertise in AI, Digital, and Cyber Compliance
Deep understanding of medical device cybersecurity
Experience as quality management representative in regulated environments
Experience with regulatory and Notified Body submission requirements
Background in medical device industry quality systems
Ability to work independently and own complex regulatory projects
Proven track record in consulting or client-facing roles
Preferred
Experience at large medical device companies (Stryker, Medtronic, Boston Scientific)
Background with consulting firms specializing in QMS setup
Startup experience (Series A/B) with QMS implementation
Specializations in cybersecurity, usability, or computer software validation
Experience scaling quality operations in high-growth environments
Knowledge of AI applications in regulatory affairs
Submission experience
Benefits
Generous stock options possible
Generous PTO for full-time
Company
Ketryx
Ketryx is an AI‑driven compliance platform that automates documentation tasks and workflows for regulated product teams.
51-200 employees
Funding
Current Stage
Growth StageTotal Funding
$57.05MKey Investors
Transformation CapitalLightspeed Venture Partners
2025-09-04Series B· $39M
2023-12-05Series A· $14M
2022-06-29Seed· $2M
Leadership Team
Erez Kaminski
CEO & Founder
Jan Pöschko
CTO & Founder
Recent News
Sourcery
2025-10-06
Company data provided by crunchbase