Qa/Ra Lead (Medtech)

TL;DR

QA/RA Lead (Medtech): Leading quality management system implementations and regulatory compliance strategies for medical device clients, focusing on repeatable QMS deployment processes leveraging AI platform capabilities. Focus on ensuring the highest quality standards for life-saving medical devices, shaping the future of regulatory affairs through innovative product development.

Location: Must be based in Boston, Massachusetts with a hybrid schedule (Monday, Tuesday, Thursday, Friday in office, Wednesday WFH option). Must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of employment Visas (including H-1B), F-1 visas, or Optional Practical Training (OPT) status at this time.

Salary: $130,000 - $150,000, plus equity options.

Company

hirify.global is saving and improving lives by making medical software safe and reliable, empowering software teams building medical applications to create safe, secure, and compliant products used by patients and providers worldwide.

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.
• Develop repeatable QMS deployment processes leveraging AI platform capabilities and automatic compliance.
• Shape the future of regulatory affairs through innovative product development.
• Ensure customer success across the entire customer engagement lifecycle.

Requirements

• 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.

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.

Culture & Benefits

• Competitive compensation and generous stock options.
• 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.