Quality Management System Specialist

Google Google · Big Tech · Mountain View, CA +1

This role focuses on managing the Quality Management System (QMS) for digital health products at Google, ensuring compliance with global health regulations, particularly concerning AI in healthcare. The specialist will advise product teams, safeguard core platforms, and engage with health authorities to shape standards. While the role operates within the context of AI in healthcare and has preferred qualifications related to LLMs and AI-agent architectures, its core function is regulatory quality management and compliance, not direct AI/ML model development or deployment.

What you'd actually do

  1. Participate in development of the most efficient way to use QMS to meet regulatory expectations.
  2. Create a system that can meet audit ready standards. Simplify design controls so they provide the least amount of friction to the developers and development pathways.
  3. Reimagine how QMS can be achieved using to meet the compliance requirement.
  4. Participate in experimenting approaches for capturing software changes, design controls to comply with regulatory requirements.
  5. Prove the defensibility and reliability of QMS data to internal stakeholders and external health authorities and auditors.

Skills

Required

  • quality engineering
  • systems architecture
  • software as a medical device
  • digital health products
  • ISO 13485
  • ISO 14971
  • IEC 62304
  • automated quality management system processes

Nice to have

  • Large Language Models (LLMs)
  • prompt engineering
  • designing AI-agent architectures
  • defending novel software quality approaches during audits or inspections
  • engaging with global health authorities or standards bodies
  • influence the development of AI-specific international standards
  • cross-functional leadership
  • managing cultural shifts towards automation
  • influencing engineering teams to adopt new quality paradigms

What the JD emphasized

  • 8 years of experience in quality engineering or systems architecture for software as a medical device or digital health products.
  • Experience in ISO 13485, ISO 14971, and IEC 62304 requirements and building automated quality management system processes.
  • Experience defending novel software quality approaches during audits or inspections by Notified Bodies or the US FDA.