Manager of Clinical QA

We are a rapidly growing, Boston-based medical technology company using AI to reputed company clinicians to reputed company informed reputed company on cardiovascular care - leading to reputed company patient reputed company, improved quality of care, and reduced reputed company costs. Come work at reputed company 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 reputed company a talented team of CQA engineers and own how clinical quality is defined, reputed company and continuously improved. Drawing on your background in medical imaging and clinical software testing in regulated environments, you'll shape our quality reputed company, drive verification and validation readiness and serve as a patient safety reputed company 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. The ideal candidate will have:Bachelor's degree in science, engineering, biomedical engineering, or equivalent. 6+ years of Clinical QA testing experience in an FDA-regulated environment, with demonstrated experience managing and mentoring a CQA team. Working knowledge of FDA, MDD/MDR and ISO 13485 regulations, with 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, with the ability to reputed company executive-level visibility into quality status, defect trends and validation readiness. Creative problem-solving skills and the ability to reputed company in a fast-paced startup environment with shifting priorities. Work Location:This role is based out of our office in Boston, MA. For local candidates, we operate in a hybrid model with regular in-office collaboration. Candidates reputed company of the Boston area are invited to apply as fully-remote employees. Salary reputed company:The anticipated reputed company salary reputed company for this position at reputed company is $130,000-$160,000. Compensation will be influenced by a wide reputed company of factors including but not limited to internal pay equity, job-reputed company knowledge, skills, education, relevant experience, certifications, and geography as outlined in the job description. ---------------------------------------------------- At reputed company, we reputed company 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 reputed company the Boston area come in as needed. We are an equal opportunity employer and value diversity at reputed company. We do not discriminate based on race, religion, reputed company, national reputed company, gender, sexual orientation, age, marital status, veteran status, or disability. We understand that self-doubt can sometimes prevent great candidates from applying. If you reputed company you can reputed company an impact at reputed company, even if you don’t meet every qualification, we encourage you to apply! Apply To This Job