About the job

Our Team:

The Global Quality Medical Device (GQMD) group’s mission is to safeguard the quality of our products by promoting the application of best practices for the development, industrialization, and manufacturing of medical devices, in accordance with applicable regulations and Sanofi Quality Systems. This mission is carried out in collaboration with the Global Device Unit for Device Development and Device Life-cycle Management, Operations, and Quality teams of Sanofi Specialty Care, General Medicines, and Vaccines in the execution of common goals.

The group provides GQ operational support for medical devices and Drug-Device combination product quality spanning development, industrialization, manufacturing, and post-market changes. The group also provides quality leadership to ensure product/process robustness, successful outcomes for regulatory submissions/inspections, and launch readiness activities.

Main responsibilities:

• Establish and maintain the global device risk management processes.
• Perform risk management according to ISO 14971 (risk management planning, hazard and harms list, Risk management reports…) and assists medical device sites in ensuring that risk management is performed in sufficient detail and in a timely manner for new device introductions and regulatory agency inspections.
• Ensure that project teams utilize appropriate risk analysis tools to assure that the Risk Management requirements are met.
• Develop and deploy appropriate Risk Management training for various internal and external Sanofi functions.
• Provide appropriate support to remediation of risk management files.
• Provide expertise and guidance to ensure a harmonized approach for all development and lifecycle management programs and perform Risk Management activities aligned with ISO 14971 including the update to Risk Management File based on post-market surveillance.
• Partner with other quality, compliance, development, and manufacturing groups to enable transparency, escalation, and action to resolve patient-safety-related issues.
• Establish and maintain linkages to other relevant risk management groups within Sanofi (e.g. Quality Risk Management, Technical Committee).
• Interface with network sites for device RMF-related topics
• Oversee trend outputs of market complaints within the network to identify possible multi-site impacts and implement the required corrective and/or preventive actions. If new risks are identified (failure modes) requiring an update of the risk analyses (pFMEA, dFMEA, use FMEA), notification of the impact to network sites.
• Interact with internal and external teams (engineering/product development /regulatory/ suppliers) to define the plan, timelines and strategy for development of the Clinical evaluation reports

• Support implementation of Design Controls elements per relevant procedures for new product development or design changes including Design History File (DHF) Maintenance
• Support Supplier Quality Engineering activities
• Support continuous improvement of projects or activities.
• Provide quality engineering support for Manufacturing Technology activities  (includes but not limited to validation, transfer, supplier selection, and quality control plan)
• Perform Impact Assessment of change controls (components, products, platforms, and processes)

About you

• Experience: relevant experience in medical device industry; relevant experience in in Risk Management; experience in connected devices is highly appreciated.  
• Soft and technical skills: ability to collaborate effectively with peers, stakeholders, and partners across the organization to positively impact business results; Knowledge in problem solving methodologies; Knowledge of ISO 13485, ISO 14971, MDR (2017/745) and 21 CFR 820
• Education: BS/MS degree in Engineering or related science discipline. An advanced degree is a plus
• Languages: Business fluent (written and oral) in English required, French or German a plus

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