Job Title: Digital Device Quality Expert - SaMD

Location: Cambridge, MA

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.

The Device Quality Expert will be accountable for the Software Quality Engineering, Risk Management and Supplier Control support of Software as Medical Device (SaMD) by leading all cGMP compliance activi-ties, as well as compliance with relevant domestic and international regulations, standards and guide-lines and customer requirements.

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?

• Represent Digital Device Quality on cross-functional teams in support of SaMD activities, collaboration with the internal and external stakeholders (See item V for list of stakeholders)
  
• Plan for and provide appropriate Quality & Compliance support for the project and application portfolios of the SaMD Digital Health Technology teams
  
• Promote quality and compliance throughout the Product life cycle and implement processes, procedures and awareness and training on Quality Management System
  
• Provide quality engineering support for design and development, and facilitate the application of controls and risk management to ensure that SaMD's are designed to be safe, effective and in compliance with the applicable regulations worldwide
  
• Work with cross-functional teams to assist in the development of quality agreements, review and approval of design & development plans, requirements, specification development, engineering studies, design verification protocols and validation protocols, ensuring appropriate selection of acceptance criteria and sampling plans.
  
• Lead and participate in design reviews
  
• Provide quality input into CAPA and nonconforming product investigations
  

• Lead all risk management activities according to ISO 14971 and TIR 57
  

• Plan, prepare and perform risk management activities for medical devices according to project phases following all relevant internal procedures, processes and external requirements for development products.
  
• Ensure that all hazards, threats and vulnerabilities associated with a medical device are identified, the associated risks are estimated and evaluated and that these risks are controlled; monitors that these risk controls are implemented, verified and validated.
  
• Maintain a close link to the human factors engineering process to meet the needs and ensure the safety of all users and patients.
  

• Manage external suppliers throughout the product lifecycle, including evaluating and qualifying suppliers, monitoring supplier performance, auditing supplier's quality management system to applicable regulations and quality standards, providing metrics, and addressing quality and regulatory issues.
  
• Author and maintain quality agreements.
  

• Collaborate with Business Product owners, Quality and Digital teams to prepare for regulatory inspections and internal audits, respond to questions and address findingsthrough corrective/preventive action plans to improve compliance and effectiveness of the quality management system.
  

• BS/M.Sc. or equivalent degree in science or engineering (e.g. software engineering, systems engineering, electrical engineering, or related engineering degree)
  
• 6+ years' experience in medical device product development focused on quality engineering related activities.
  
• 2 - 3 years relevant experience in risk management for medical devices
  
• Strong experience in software development and medical device life cycle management
  
• Good knowledge of and experience in performing safety and cybersecurity risk management for medical devices
  
• Proficient in usage of risk assessment methods, e.g.: Hazard Analysis (PHA), Software Risk Analysis, Fault Tree Analysis (FTA), Failure Modes and Effects Analysis (FMEA)
  
• Good knowledge of medical device regulations and international standards, e.g.: ISO 13485, 21 CFR 820, IEC 62304, ISO 14971, TIR 57, MDR, ISO/TR 80001, IEC TR 80002-1
  

• 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.