Head of Quality Systems (Digital Therapeutics / SaMD)

Company Description

Lumosity, developed by Lumos Labs, Inc., is a leading brain training program that features over 50 cognitive games designed by scientists to enhance core cognitive abilities. These games are fun, adaptively challenging, and accessible to users of all ages, promoting continuous cognitive engagement. Lumos Labs is also the founder of the Human Cognition Project, a research initiative partnering with over 90 universities to facilitate innovative cognitive studies. By offering access to its training tools and datasets, Lumos Labs supports impactful research that advances the understanding of human cognition.

Overview : We are seeking an experienced Quality leader to own and oversee the Quality Management System (QMS) for our FDA-regulated digital therapeutics division. This is a hands-on leadership role responsible for day-to-day ownership and operation of the QMS.

Responsibilities

QMS Ownership & Oversight:

• Own and maintain the Quality Management System in compliance with the FDA Quality Management System Regulation (QMSR; 21 CFR Part 820), aligned with ISO 13485:2016.
• Own complaint handling processes, investigations, and Medical Device Reporting (MDR) compliance.
• Lead CAPA and nonconformance management.
• Oversee post-market surveillance systems, including monitoring of real-world product performance.
• Ensure the organization maintains continuous inspection readiness.

Design & Development Quality

• Oversee Design History File (DHF) maintenance, risk management documentation (ISO 14971), and verification and validation activities.
• Ensure appropriate quality processes for Software as a Medical Device (SaMD) development.
• Establish and oversee software design change control processes, ensuring appropriate documentation, impact assessment, risk management updates, and verification/validation for product updates and modifications in compliance with FDA QMSR and applicable software lifecycle standards (e.g., IEC 62304).

Audit & Inspection Management

• Lead internal audits and coordinate external or mock audits.
• Serve as the primary Quality representative during FDA inspections.
• Drive corrective actions and remediation activities when needed.

Cross-Functional Partnership

• Partner closely with Product, Engineering, Clinical, Regulatory consultants, and Operations teams.
• Promote a culture of quality appropriate for a software-driven medical product organization.

Qualifications

• 8+ years of experience in medical device quality roles.
• Direct experience implementing, maintaining, or overseeing a medical device QMS under FDA QMSR (21 CFR Part 820) and/or ISO 13485.
• Experience serving as primary steward of a Quality Management System.
• Strong hands-on experience with complaint handling, CAPA, nonconformance management, and post-market surveillance.
• Experience supporting or participating in FDA inspections.
• Experience with Software as a Medical Device (SaMD) or software-driven medical products.
• Familiarity with ISO 13485, ISO 14971, and IEC 62304.
• Experience in digital therapeutics, digital health, or software-based medical devices.
• Exposure to EU MDR / CE marking processes.
• ISO 13485 Internal Auditor or Lead Auditor certification (or equivalent audit training).