Director of Quality Systems

Elucid•Boston, MA

1d•$175,000 - $225,000•Hybrid

About The Position

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.

Requirements

7+ years of Quality Management or Regulatory Affairs experience in the medical device industry.
2–5+ years of people management experience.
Deep hands-on experience guiding software development lifecycle activities (V&V, testing strategy, design transfer, release processes, etc.) with Product 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.
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.

Nice To Haves

Advanced degree in Life Sciences, Engineering or a related discipline preferred.

Responsibilities

Own quality strategy execution and our quality management system.
Lead a team of quality professionals from the ground up.
Shape how a novel, machine learning powered SaMD product is developed, cleared globally and evolves over its lifecycle.
Partner closely with R&D, Regulatory Affairs, Clinical and Product.
Guide software development lifecycle activities (V&V, testing strategy, design transfer, release processes, etc.) with Product teams to maintain compliance and champion a culture of quality.
Lead quality management system (QMS) activities including audits, CAPA, risk management and post-market compliance requirements such as vigilance reporting and change assessments.
Translate complex regulatory requirements into actionable guidance and drive effective, cross-functional execution of quality processes with R&D, Clinical and Product teams.