Manager, Post-Market Quality
Element Science
This listing was originally posted on Element Science's careers page. Formulate is an equal opportunity job aggregator and is not involved in the hiring process. Where salary information is estimated, it is derived from BLS industry benchmarks and may differ from actual compensation.
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Upgrade to Pro — $25/moElement Science, Inc. is a medical device and digital health company redefining how patients with heart disease are monitored and treated as they transition from the hospital to the home. Our mission is to improve outcomes for patients at risk of life-threatening cardiac events through innovative solutions at the intersection of clinical-grade wearables, advanced algorithms, and therapy delivery.
We are entering an exciting phase of growth as we move from development into early commercialization. Our approach combines hardware, software, and services to deliver a more personalized and seamless patient experience—designed with both patients and clinicians in mind. Our product, a wearable patch defibrillator, is designed for patients with a temporary elevated risk of sudden cardiac arrest, addressing a significant and underserved population of over 500,000 patients in the U.S. By focusing on comfort, usability, and clinical effectiveness, we aim to transform the standard of care during this critical period. Headquartered in the San Francisco Bay Area, Element Science is backed by leading healthcare and technology investors, including Third Rock Ventures, GV (Google Ventures), Deerfield Healthcare, Qiming Venture Partners USA, Cormorant Asset Management, and Invus Opportunities.
SUMMARY OF ROLE:
The Post Market Quality Manager is responsible for the end-to-end lifecycle of product feedback and quality issues. This role will lead the complaint process from initial intake and determination through investigation, regulatory reportability assessment and complaint closure including 14-day customer letters where required while maintaining regulatory compliance. This role will also drive trending of post-market data and translate into actionable data for Management and cross-functional stakeholders.
RESPONSIBILITIES:
Intake Leadership & Guidance
Investigation, Reportability & Closure
Post-Market Analysis & Metrics
DMEPOS Compliance
QUALIFICATIONS:
BENEFITS:
Element Science offers a very competitive salary and benefits package including, but not limited to:
Element Science is an Equal Opportunity Employer. All candidates will be evaluated on the basis of their qualifications for the job in question. We do not base our employment decision on an employee's or applicant's race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), political affiliation, military service, or other non-merit-based factors prohibited by local, state, or federal law.
At this time, we are unable to offer relocation assistance at Element Science.
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MEDICAL DEVICES
Wearable device to prevent cardiac death
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