Principal Quality Engineer - Remote Role in AI Healthcare

About the Role

We are seeking a Principal Quality Engineer to join our team at RecovryAI. This remote Principal Quality Engineer position plays a pivotal role in ensuring the quality and compliance of our innovative AI-driven health solutions. You will lead the quality strategy across our software-driven platform, ensuring that quality is embedded throughout the product lifecycle.

What You'll Do

• 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.
• Collaborate closely with Regulatory, Engineering, Product, Clinical, Security, and Operations teams to ensure alignment with FDA QMSR, ISO standards, and internal quality system requirements.
• Own and lead product risk management activities, including the development and maintenance of the Risk Management File, considering software, AI/ML, cybersecurity, and clinical workflow risks.
• Define, oversee, and approve software verification and validation (V&V) strategies, ensuring robust traceability from user needs through test execution.
• Assist in driving Quality Management System (QMS) development and implementation, aligning practices with the needs of a growing digital health organization.
• Manage activities related to the electronic Quality Management System (eQMS), ensuring sustained effectiveness and audit readiness.
• Lead post-market surveillance activities, including complaint handling and communication of product quality metrics to stakeholders.
• Collect and analyze quality, risk, and product performance data to support informed decision-making and continuous improvement.

Requirements

• 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 experience supporting software-driven or AI-enabled products.
• Direct experience with SaMD products strongly preferred.
• Knowledge of FDA regulations, ISO standards, and applicable guidance documents.
• Proficient in risk management tools and design V&V processes.
• Hands-on experience leading software requirements management and testing activities.
• ASQ Certified Software Quality Engineer (CSQE) or Certified Quality Engineer (CQE) preferred.

Nice to Have

• Experience with eQMS platforms and document control management.
• Excellent problem-solving and analytical skills.

What We Offer

• Fully remote position with flexible working hours.
• Opportunity to make a significant impact in medical AI.
• Ownership of meaningful projects that affect patient outcomes.
• Competitive salary and equity compensation.
• Growth opportunities as we scale our team and product.

Join RecovryAI and be part of a mission-driven team focused on transforming post-operative recovery through AI-enabled digital health solutions. As a remote Principal Quality Engineer, you will play a crucial role in advancing product development and quality compliance, helping to build a strong foundation for innovation and long-term growth.