Director of Quality Systems

Elucid; Boston (MA); Hybrid; USD 175,000 - 225,000; Full time

Benefits offered by this job

Hybrid work model

Office in Boston

Job summary

Elucid, a Boston-based medical technology company leveraging AI for cardiovascular care, is seeking a Director of Quality Systems to own the quality strategy and QMS. You will lead a ground-up quality team, shaping how a novel SaMD product is developed, cleared globally, and evolved with ongoing lifecycle management, collaborating closely with R&D, Regulatory, Clinical and Product teams.

The ideal candidate brings 7+ years in Quality Management or Regulatory Affairs in medical devices, 2–5+

Qualifications

• 7+ years of Quality Management or Regulatory Affairs experience in the medical device industry and 2–5+ years of people management experience. SaaS product experience preferred.
• Advanced degree in Life Sciences, Engineering or a related discipline.
• Hands-on experience guiding software development lifecycle activities in an agile environment with monthly releases, working with Product and Engineering to maintain compliance.
• Demonstrated expertise in SaMD regulatory frameworks, including FDA Class II and EU MDR Class IIa/IIb; familiarity with 21 CFR Part 820, ISO 13485, ISO 14971, IEC 62304, IEC 62366.
• Experience leading quality management system (QMS) activities including audits, CAPA, risk management and post-market compliance such as vigilance reporting and change assessments.
• Strong collaboration and communication skills, translating regulatory requirements into actionable guidance for cross-functional execution.

Responsibilities

• Own quality strategy execution and our quality management system (QMS).
• Lead a team of quality professionals from the ground up.
• Shape how a novel, ML-powered SaMD product is developed, cleared globally, and evolves over its lifecycle.
• Partner with R&D, Regulatory Affairs, Clinical and Product to drive quality processes across teams.
• Translate complex regulatory requirements into actionable guidance and drive cross-functional execution.

Skills

Quality leadership

Regulatory compliance

Cross-functional collaboration

Communication skills

Project management

Education

Advanced degree in Life Sciences, Engineering or related discipline

Tools

QMS Audits

CAPA

Job description

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. If you're a SaMD quality leader who thrives at the intersection of science, strategy and compliance, we would love to build together to revolutionize cardiovascular care.

The ideal candidate will have:

• 7+ years of Quality Management or Regulatory Affairs experience in the medical device industry and 2–5+ years of people management experience. Experience with SaaS product preferred.
• Advanced degree in Life Sciences, Engineering or a related discipline.
• Deep hands-on experience guiding software development lifecycle activities in an agile environment with monthly releases (testing strategy, design transfer, release processes, etc.), working with Product and Engineering teams to maintain compliance and champion a culture of quality.
• Demonstrated expertise in SaMD regulatory frameworks, including familiarity with FDA Class II devices and EU MDR Class IIa/IIb products, and working knowledge of standards such as 21 CFR Part 820, ISO 13485, ISO 14971, IEC 62304, and IEC 62366.
• Experience leading quality management system (QMS) activities including audits, CAPA, risk management and post-market compliance requirements such as vigilance reporting and change assessments.
• Strong collaboration and communication skills, with the ability to translate complex regulatory requirements into actionable guidance and drive effective, cross‑functional execution of quality processes with R&D, Clinical and Product teams.

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.

Salary Range:

• The anticipated base salary range for this position at Elucid is $175,000-$225,000. Compensation will be influenced by a wide array of factors including but not limited to internal pay equity, job‑related knowledge, skills, education, relevant experience, certifications, and geography as outlined in the job description.

At Elucid, we believe the best work happens in a flexible hybrid environment. 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.

We are an equal opportunity employer and value diversity at Elucid. We do not discriminate based on race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability.