Quality Management System and Evidence Control Specialist

Quality Management System and Evidence Control Specialist Google - 4.3 Mountain View, CA Job Details Full-time $144,000 - $209,000 a year 1 hour ago Qualifications ISO standards Bachelor's degree Investigation evidence collection Design controls Biomedical regulatory compliance Evidence collection Full Job Description Minimum qualifications: Bachelor's degree in a technical or scientific discipline. 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.

Preferred qualifications:

Experience in a startup or fast-growing technical environment. Experience managing the regulatory boundary between general-purpose infrastructure and regulated applications. Familiarity with integrating regulatory requirements into CI/CD pipelines and developer workflows.

Generative AI/LLM Experience:

Proven ability to leverage AI for automating QMS or evidence-related tasks. Demonstrated success in aligning Engineering, Product, and Legal teams on new compliance paradigms. Strong project management skills and attention to detail. 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 partner 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 get to 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.

Individual pay is determined by factors including job-related skills, experience, and relevant education or training.

US:

$144000 - $209000 (USD) + 15% bonus target + bonus + equity + benefits Learn more about benefits at Google. Responsibilities Run the Quality Management System (QMS) process, ensuring evidence collection and control to meet statutory and regulatory requirements. Maintain a state of 'inspection readiness' through proactive evidence collection. Administer the evidence control system and associated processes. Coordinate logistics for external regulatory inspections and third-party audits to provide necessary evidence as required by auditors and inspectors. Collaborate with Engineering to translate contemporary technical workflows, such as code submissions and automated checks, into rigorous SaMD compliance evidence to support regulatory expectations. Google is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements. See also Google's EEO Policy and EEO is the Law. If you have a disability or special need that requires accommodation, please let us know by completing our Accommodations for Applicants form.