Element 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. 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 Sr.

Manager, Quality Systems is responsible for day-to-day operation and continuous improvement of Element Science’s Quality System. The role is responsible for Document Control, Training Program, Change Control, Internal External Audit Program, Management Review, Nonconformance management and CAPA management. The Manager, Quality Systems serves as deputy management representative representing the organization in internal and external audits.

Requirements

including managing external DME audits maintaining quality documentation and ensuring adherence to regulatory standards. This role supports EU MDR deliverables in collaboration with external regulatory consultant. This role plays a key part in sustaining a compliant, audit ready QMS that upholds patient safety and organizational integrity.

Support EU MDR compliance activities in partnership with external regulatory consultants, including CERs, PSURs, and PMS deliverables Maintain quality documentation and records necessary to support BSI certification activities and ongoing

RESPONSIBILITIES

: Lead, mentor, and develop Quality Systems team members, fostering a culture of quality, accountability, collaboration, and continuous improvement Partner cross-functionally to investigate quality issues, interpret data trends, and drive timely, risk-based decisions Build and maintain strong working relationships with internal stakeholders, external auditors, and regulatory partners Own and maintain the Document Control system, ensuring controlled documents remain accurate, current, compliant, and properly version-controlled Administer and continuously enhance the company training program, ensuring timely completion, training effectiveness, and maintenance of compliant training records Own the CAPA program, including driving timely resolution of aging CAPAs, ensuring robust root cause investigations, and monitoring closure effectiveness and metrics Manage Nonconformance (NC) processes from initiation through final disposition and closure, ensuring timely and compliant execution Lead Management Review activities, including development of quality metrics, trend analysis, and executive-ready Quality Management Review (QMR) materials Monitor, analyze, and trend quality system metrics to proactively identify systemic risks, drive corrective actions, and support continuous improvement initiatives Support post-market surveillance activities, including maintenance of associated documentation and reporting