Manager of Clinical QA
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! Our Clinical Quality Assurance (CQA) team is the quality backbone of our AI-enabled cardiovascular imaging software, embedding rigorous, risk-based testing practices directly into how we build and release SaMD products. As CQA Manager, you'll lead a talented team of CQA engineers and own how clinical quality is defined, measured and continuously improved. Drawing on your background in medical imaging and clinical software testing in regulated environments, you'll shape our quality vision, drive verification and validation readiness and serve as a patient safety advocate embedded in our agile engineering teams. As a hands-on quality leader who thrives at the intersection of clinical rigor and fast-moving software development, you'll directly impact how cardiovascular disease is detected and treated.
Requirements
- Bachelor's degree in science, engineering, biomedical engineering, or equivalent.
- 6+ years of Clinical QA testing experience in an FDA-regulated environment.
- Demonstrated experience managing and mentoring a CQA team.
- Working knowledge of FDA, MDD/MDR and ISO 13485 regulations.
- Hands-on experience in documentation and quality processes in a highly regulated setting.
- Experience integrating Clinical QA practices into an agile SDLC, including verification strategy development, exploratory and automated testing and design controls compliance.
- Excellent communication skills and meticulous attention to detail.
- Ability to provide executive-level visibility into quality status, defect trends and validation readiness.
- Creative problem-solving skills.
- Ability to thrive in a fast-paced startup environment with shifting priorities.
Responsibilities
- Lead a talented team of CQA engineers.
- Own how clinical quality is defined, measured and continuously improved.
- Shape our quality vision.
- Drive verification and validation readiness.
- Serve as a patient safety advocate embedded in our agile engineering teams.
Benefits
- Flexible hybrid environment
- Equal opportunity employer
- Diversity valued
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Manager
