RecovryAI · 18 hours ago
Principal Quality Engineer
United States
Full-time
Remote
Lead/Staff
8+ years expRecovryAI is redefining post-operative recovery with regulated, patient-facing clinical AI and advanced digital health solutions. The Principal Quality Engineer is a critical role responsible for shaping and executing quality strategy across the software-driven, AI-enabled digital health platform, managing quality processes throughout the product lifecycle.
Computer Software
Hiring Manager
Priya Khatri
Responsibilities
Serve as the primary Quality representative across product development, software engineering, clinical, and sustaining activities, ensuring quality and compliance are embedded throughout the full product lifecycle
Partner closely with Regulatory, Engineering, Product, Clinical, Security, and Operations teams to ensure alignment with FDA QMSR (21 CFR Part 820), ISO 13485, ISO 14971, IEC62304, software lifecycle expectations, and internal quality system requirements
Own and lead product risk management activities, including the development, maintenance, and continuous updating of the Risk Management File, with integrated consideration of software, AI/ML, cybersecurity, data, and clinical workflow risks
Define, oversee, and approve software verification and validation (V&V) strategies, including automated and manual testing approaches, ensuring robust traceability from user needs and system requirements through test execution and results
Lead the definition, review, and lifecycle management of requirements (e.g., user needs, system requirements, software requirements), ensuring they are clear, testable, risk-informed, and suitable for agile development environments
Assist with driving Quality Management System (QMS) development and implementation, to align quality practices with the needs of a growing digital health organization
Manage activities related to the electronic Quality Management System (eQMS), including document control, change management, training, and system configuration to ensure sustained effectiveness and audit readiness
Lead post-market surveillance activities, including complaint handling, issue trending, investigation oversight, and communication of product quality and performance metrics to leadership and cross-functional stakeholders
Collect, analyze, trend, and communicate quality, risk, and product performance data to support informed, risk-based decision-making and continuous improvement
Actively contribute to Engineering, Software Development, Product Development, and Risk Management meetings as the dedicated Quality representative
Support commercial readiness and scale-up initiatives, ensuring quality systems, documentation, and controls are in place to support organizational growth and long-term sustainability, including SOC2 and HIPPA compliance and 3rd party audits
Qualification
Required
Bachelor's degree in Engineering, Computer Science, Biomedical Engineering, or a related technical discipline (Master's preferred)
8+ years in the medical device industry with demonstrated experience supporting software-driven or AI-enabled products, with emphasis on Design Assurance, Software Quality, and Product Development support
Direct experience with SaMD products strongly preferred
Knowledge of FDA regulations, ISO 13485, ISO 14971, IEC 62304 and applicable FDA SAMD guidance documents
Proficient in risk management tools (FMEA, FTA) and design V&V processes
Hands-on experience leading software requirements management, software risk analysis, and software testing activities, including formal V&V
Hands-on experience with eQMS platforms and document control management
Experience leading complaint handling, post-market surveillance, and trending activities
Excellent problem-solving, analytical, and root cause investigation skills
Preferred
ASQ Certified Software Quality Engineer (CSQE) or Certified Quality Engineer (CQE) preferred
Benefits
Competitive compensation, including employee stock options and health benefits
Company
RecovryAI
2-10 employeesFunding
Current Stage
Early StageCompany data provided by crunchbase