Quality Management System Specialist

Google•Mountain View, CA

1d•$144,000 - $209,000

About The Position

The Digital Health Regulatory Quality and Strategy (DHRQS) team serves as the advisors helping Google navigate the complex and evolving global health regulatory landscape. Our team is at the forefront of defining how AI can safely and effectively transform healthcare. We focus on three primary pillars. We provide the regulatory strategy and operational infrastructure to help product teams across Google build and launch regulated products globally. We safeguard Google’s core platforms and general-purpose models from being unintentionally regulated or exposed to liability, ensuring a clear separation between regulated features and core business services and we actively engage with global health authorities to shape international standards and national policies, ensuring AI regulations balance innovation with safety. In this role, you will operate at the nexus of the health ecosystem, technological advancement, and regulatory expertise to steer Google’s platforms in supporting billions of individuals throughout their health experiences. You will work with the engineers and product builders along with clinicians who are passionate about applying technology in health. Google for Health is a company-wide effort to help billions of people be healthier. We work toward this vision by meeting people in their everyday moments and empowering them to stay healthy and partnering with care teams to provide more accurate and accessible care. Our teams are applying our expertise and technology to improve health outcomes globally – with high-quality information and tools to help people manage their health and wellbeing, solutions to transform care delivery, research to catalyze the use of artificial intelligence for the screening and diagnosis of disease, and data and insights to the public health community.

Requirements

Bachelor’s degree in Engineering, Computer Science, Operations, a related technical field, or equivalent practical experience.
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.

Nice To Haves

Advanced degree in a relevant technical, or quality discipline.
Experience with Large Language Models (LLMs), prompt engineering, or designing AI-agent architectures.
Experience defending novel software quality approaches during audits or inspections by Notified Bodies or the US FDA.
Experience engaging with global health authorities or standards bodies to influence the development of AI-specific international standards.
Exceptional cross-functional leadership skills, with a track record of managing cultural shifts towards automation and influencing engineering teams to adopt new quality paradigms.

Responsibilities

Participate in development of the most efficient way to use QMS to meet regulatory expectations.
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.
Reimagine how QMS can be achieved using to meet the compliance requirement.
Participate in experimenting approaches for capturing software changes, design controls to comply with regulatory requirements.
Prove the defensibility and reliability of QMS data to internal stakeholders and external health authorities and auditors.