Senior Quality Engineer (all genders) - limited until 31.08.2026

About the job  

Our Team: 

The Global Device and Packaging Quality (GDPQ) 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 and Packaging Unit (GDPU) 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 global quality 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: 

Senior Quality Engineers drive new product development/life-cycle management design control activities by leading all cGMP compliance activities on assigned projects/products. This includes compliance with relevant Sanofi policies and procedures, domestic and international regulations, standards and guidelines and customer requirements. Senior Quality Engineers ensure application of quality engineering and risk management principles early on in the product development process and through design control throughout the entire life-cycle of a product.  

Depending on the scope of responsibilities, Quality Engineers are accountable on one or more of the following: 

​​Design History File (DHF) Maintenance: 

• Accountable for DHF oversight and maintenance for the post-launch stage in collaboration with the global device unit design center.   

• Ensure DHF maintenance procedures and relevant processes are robust, standardized, and adequately maintained following regulatory requirements and best practices.   

• Create and maintain all DHFs structure according to defined process and system in coordination with project teams accountable for new product development or design change projects. 

• Support audits or inspections requiring access to DHFs. 

• Perform DHF reviews\audits as required to support Design Reviews, audit preparations or part of continuous improvement activities related to DHF maintenance process. 

• Lead DHF remediation efforts. 

Continuous Improvement: 

• Lead continuous improvement projects or activities which may include product or process improvements and remediation efforts (ie DHF, Risk Management Files, etc.) in collaboration with other platform quality engineers or functions. 

• Contributing to network forums to support for aligned process execution in the different networks 

Change Controls: 

• Coordinating the Device & Packaging Change Board for GDPU and change control communication within the network 

• Supporting the assessment for network impact and design consi