Digital Device Quality Expert - SaMD

R2730912 Digital Device Quality Expert - SaMD

Location: US / Cambridge (U.S.) / Cambridge Crossing / 450 Water Street - Office Building

About the Job

At Sanofi, we're committed to providing the next-gen healthcare that patients and customers need. It's about harnessing data insights and leveraging AI responsibly to search deeper and solve sooner than ever before. Join our Digital Quality Operations as Digital Device Quality Expert - SaMD and you can help make it happen. Your job? Developing globally scalable AI and machine learning solutions that help us get new clinical products to patients faster and more efficiently.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main Responsibilities:

• Lead software quality engineering, risk management, and supplier control for Software as Medical Device (SaMD) products, ensuring compliance with regulations, standards, and customer requirements.

• Provide quality engineering support throughout the product lifecycle, from design and development to post-market activities, to ensure safe and effective products.

• Conduct risk management activities according to ISO 14971 and TIR 57, identifying hazards, estimating and evaluating risks, and implementing controls to mitigate them.

• Manage external suppliers, including evaluation, qualification, performance monitoring, and auditing of their quality management systems.

• Collaborate with cross-functional teams to prepare for regulatory inspections and internal audits, ensuring compliance and addressing findings through corrective and preventive actions.

About You:

• Bachelor's or Master's degree in science or engineering, with a focus on software, systems, or electrical engineering.

• Minimum of 5 years' experience in medical device product development, with expertise in quality engineering and risk management.

• Proficiency in software development and medical device lifecycle management, with strong knowledge of relevant regulations and standards.

• Excellent communication and presentation skills, with the ability to engage stakeholders and drive quality and compliance initiatives.

• Self-starter attitude with the ability to learn quickly and adapt to different technologies and regulatory environments.

Why Choose Us

• Bring the miracles of science to life alongside a supportive, future-focused team.

• Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally .

• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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Pursue progress , discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

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