Quality Management System Specialist

Quality Management System Specialist corporate_fare Google place Mountain View, CA, USA bar_chart Mid Mid Experience driving progress, solving problems, and mentoring more junior team members; deeper expertise and applied knowledge within relevant area.

Minimum qualifications:

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.

Preferred qualifications:

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. About the job 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. 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.