Manager, Quality Systems

Element Science•Redwood City, CA

1d•$144,000 - $154,000

About The Position

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. 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.

Requirements

5+ years of progressive Quality Assurance experience within the medical device industry, including experience in regulated manufacturing environments
2+ years of people leadership or management experience, with demonstrated ability to lead and develop high-performing teams
Strong working knowledge of ISO 13485, 21 CFR Part 820, FDA Quality System Regulations, and EU MDR requirements
Hands-on experience utilizing eQMS and PLM systems to support quality and compliance initiatives
Ability to interpret, implement, and adapt to evolving regulatory requirements, including DME quality system standards
Solid understanding of core quality processes, including CAPA, nonconformance management, complaint handling, change control, and internal auditing
Experience partnering with external auditors and regulatory agencies, including BSI, FDA, CHAP, or equivalent organizations
Demonstrated ability to manage multiple priorities and drive execution in a fast-paced, evolving environment
Strong analytical and problem-solving skills, with the ability to identify trends, summarize findings, and communicate recommendations to leadership

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 requirements
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 CE mark compliance
Own and execute the Internal Audit Program, including audit planning, scheduling, execution, findings management, and verification of corrective action closure
Coordinate CHAP accreditation activities and ongoing DME compliance requirements, including preparation for and management of external audits
Partner with external auditors and regulatory agencies to support inspections, audits, and compliance readiness activities
Ensure the Quality Management System remains compliant with FDA, ISO 13485, CHAP, EU MDR, and other applicable regulatory and quality standards
Support system validation activities, process improvements, and ongoing enhancements to quality systems and tools as needed