Quality Management System and Evidence Control Specialist

Quality Management System and Evidence Control Specialist

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corporate_fareGoogleplaceMountain View, CA, USA

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Mid

Experience driving progress, solving problems, and mentoring more junior team members; deeper expertise and applied knowledge within relevant area.

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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.

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Google is proud to be an equal opportunity and affirmative action employer. We are committed to building a workforce that is representative of the users we serve, creating a culture of belonging, and providing an equal employment opportunity regardless of race, creed, color, religion, gender, sexual orientation, gender identity/expression, national origin, disability, age, genetic information, veteran status, marital status, pregnancy or related condition (including breastfeeding), expecting or parents-to-be, criminal histories consistent with legal requirements, or any other basis protected by law. See also Google's EEO Policy, Know your rights: workplace discrimination is illegal, Belonging at Google, and How we hire.

If you have a need that requires accommodation, please let us know by completing our Accommodations for Applicants form.

Google is a global company and, in order to facilitate efficient collaboration and communication globally, English proficiency is a requirement for all roles unless stated otherwise in the job posting.

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