QA/RA Consultant

Boston, Massachusetts, United States. Posted 14 months ago

The role

You will lead quality management system implementations and regulatory compliance strategies for medical device clients. You will use an AI-powered compliance platform to drive repeatable QMS deployment processes.

What you will do

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.
Ensure customer success across the entire customer engagement lifecycle.

Required qualifications

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.

Nice to have

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.
Experience working in an early stage, product-based start up.

Benefits

Competitive compensation
Generous stock options possible
Work in an exciting field with a positive impact on the world
Opportunity to learn and grow as part of a global team
Generous PTO for full-time

About the company

Ketryx is saving and improving lives by making medical software safe and reliable. They empower software teams building medical applications to create safe, secure, and compliant products using an AI-powered platform.