Quality Management System and Evidence Control Specialist

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

This role focuses on managing the Quality Management System (QMS) and evidence control for digital health products, ensuring compliance with global regulatory requirements, particularly for AI in healthcare. The specialist will collaborate with engineering and product teams to translate technical workflows into compliance evidence and prepare for regulatory inspections and audits. While the role operates within the context of AI in healthcare, the core responsibilities are in quality management and regulatory compliance, not direct AI/ML model development or research.

What you'd actually do

  1. Run the Quality Management System (QMS) process, ensuring evidence collection and control to meet statutory and regulatory requirements.
  2. Maintain a state of 'inspection readiness' through proactive evidence collection.
  3. Administer the evidence control system and associated processes.
  4. Coordinate logistics for external regulatory inspections and third-party audits to provide necessary evidence as required by auditors and inspectors.
  5. Collaborate with Engineering to translate contemporary technical workflows, such as code submissions and automated checks, into rigorous SaMD compliance evidence to support regulatory expectations.

Skills

Required

  • QMS administration
  • evidence control
  • regulatory requirements
  • ISO 13485
  • IEC 62304
  • ISO 14971
  • software as a medical device (SaMD) compliance

Nice to have

  • startup or fast-growing technical environment experience
  • managing regulatory boundary between general-purpose infrastructure and regulated applications
  • integrating regulatory requirements into CI/CD pipelines
  • Generative AI/LLM Experience: Proven ability to leverage AI for automating QMS or evidence-related tasks.
  • aligning Engineering, Product, and Legal teams on new compliance paradigms
  • project management skills
  • attention to detail

What the JD emphasized

  • 8 years of experience in evidence control and QMS administration in a regulated environment.
  • Experience in ISO 13485, IEC 62304, and ISO 14971 as they apply to software as a medical device and artificial intelligence products.