Principal Quality Engineer (AI/ML Digital Health)

Company Overview

RecovryAI is redefining post-operative recovery with regulated, patient-facing clinical AI and advanced digital health solutions. As a growing company, we are building a strong foundation for quality, compliance, and continuous improvement to support our mission.

Position Overview  

The Principal Quality Engineer (PQE) is a critical, hands-on role responsible for shaping and executing quality strategy across RecovryAI’s software-driven, AI-enabled digital health platform. This role spans design assurance, software quality, cybersecurity, and post-market surveillance. This position will manage quality processes across the product lifecycle, support software development teams, lead complaint handling and trending analysis, and maintain the electronic Quality Management System (eQMS).

Essential Job Functions

· 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 3^rd party audits.

Cross-Functional Engagement & Leadership Attributes

·  Exhibit excellent interpersonal, collaboration, and leadership skills with the ability to work cross-functionally and influence teams at all levels.

·  Demonstrate self-motivation, a positive, can-do attitude, and the ability to motivate and engage others in achieving quality, product, and business objectives.

·  Self-starter with a proactive approach to driving continuous improvement. Comfortable establishing processes and documentation with an eye for system creation and repeatability.

Requirements/Qualifications

·  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.

·  ASQ Certified Software Quality Engineer (CSQE) or Certified Quality Engineer (CQE) preferred

What We Offer

-     Fully remote position with flexible working hours

-     Opportunity to make a significant impact in medical AI

-     Direct collaboration with deeply experienced technical leadership

-     Growth opportunities as we scale our team and product

-     Competitive compensation, including employee stock options and health benefits

At RecovryAI, you will join a collaborative, mission-driven team focused on transforming post-operative recovery through AI-enabled digital health solutions and clinically informed virtual care. In this role, you will play a visible and influential role in advancing product development, quality compliance, and commercial readiness—helping build the quality foundation that supports innovation and long-term growth.