Director of Quality Systems

About the role

We are a rapidly growing, Boston-based medical technology company using AI to enable clinicians to make informed decisions on cardiovascular care—leading to better patient outcomes, improved quality of care, and reduced healthcare costs. Come work at Elucid and be part of delivering on our mission to prevent heart attacks and strokes!

At Elucid, quality isn't a checkpoint. It's core to how we bring transformative cardiovascular AI to physicians. This is a new role for us, created as we build out our quality function, so you'll have real latitude to shape the team and the system. As our Director of Quality Systems, you'll own quality strategy execution and our quality management system, and lead a team of quality professionals from the ground up. You'll shape how a novel, machine learning-powered SaMD product is developed, cleared globally, and evolves over its lifecycle, partnering closely with R&D, Regulatory Affairs, Clinical, and Product.

Responsibilities

• Own quality strategy execution and the quality management system (QMS) for a machine learning-powered SaMD product.
• Lead a team of quality professionals from the ground up, shaping the team and system.
• Guide software development lifecycle activities in an agile environment with monthly releases, including testing strategy, design transfer, and release processes.
• Maintain compliance and champion a culture of quality in collaboration with Product and Engineering teams.
• Oversee QMS activities such as audits, CAPA, risk management, and post-market compliance requirements (e.g., vigilance reporting and change assessments).
• Translate complex regulatory requirements into actionable guidance and drive cross-functional execution of quality processes with R&D, Clinical, and Product teams.

Requirements

• 7+ years of Quality Management or Regulatory Affairs experience in the medical device industry.
• 2–5+ years of people management experience.
• Advanced degree in Life Sciences, Engineering, or a related discipline.
• Deep hands-on experience with SaMD regulatory frameworks, including familiarity with FDA Class II devices and EU MDR Class IIa/IIb products.
• Working knowledge of standards such as 21 CFR Part 820, ISO 13485, ISO 14971, IEC 62304, and IEC 62366.
• Experience with SaaS products preferred.

Skills

• Strong collaboration and communication skills.
• Ability to translate complex regulatory requirements into actionable guidance.
• Experience in agile software development environments with frequent releases.

Work Location

This is an on-site role based out of our office in Boston, MA. Our team is hybrid and has a preference for local candidates or those located in eastern time zones in the continental U.S. Boston-area employees are encouraged to work from the office on Mondays and Wednesdays, with the option to come in additional days if they prefer. Fully remote employees outside the Boston area come in as needed.

Pay

The anticipated base salary range for this position at Elucid is $175,000–$225,000. Compensation will be influenced by factors including internal pay equity, job-related knowledge, skills, education, relevant experience, certifications, and geography.