Job Title: Device Quality Engineer - Device Risk Management and Surveillance Excellence
About the Job
As Device Quality Engineer - Device Risk Management and Surveillance Excellence within our Global Device and Packaging Unit (GDPU), you will lead critical global processes for patient safety and regulatory compliance. You are accountable for maintaining and continuously improving Device Risk Management, Clinical Evaluation, and Post-Market Surveillance processes, ensuring Medical Devices and Drug-Device Combination products comply with ISO 14971, MDR, and other relevant regulations throughout their lifecycle.
You will deliver expert quality support for risk management and post-market surveillance activities across the development pipeline and post-launch lifecycle management. The role involves collaborating with cross-functional teams and external stakeholders to ensure expert evaluations on patient safety and compliance matters.
Main Responsibilities
Lead Device Risk Management, Clinical Evaluation, and Post-Market Surveillance processes across Sanofi as the global process owner
Ensure SOPs align with applicable regulations and industry standards while driving continuous improvement initiatives
Analyze post-market data to identify trends, multi-site impacts, and implement corrective actions
Ensure Device Risk Management Files accurately reflect current product risks and remain updated throughout the product lifecycleProvide guidance on harmonized risk management approaches aligned with ISO 14971 across all development and lifecycle management programs
Develop new tools, comprehensive training programs and mentor colleagues on process execution, best practices, and risk management methodologies
Ensure project teams utilize appropriate risk analysis tools (FMEAs, PHA) and facilitate dFMEA moderation sessions
Author and maintain post market surveillance deliverables throughout the product lifecycle
Support Design Controls implementation for new product development and design changes, including Design History File maintenance
Partner with quality, compliance, development, and manufacturing teams to ensure transparency, coordination, and patient safety actions
About You
Basic Qualifications
BS degree in Engineering, Business, Life Sciences or related science discipline.
MS degree is a plus
5+ years of medical device industry experience.
3+ years of relevant experience in in Risk Management and Post-Market Surveillance for medical devices and/or drug-device combination products.
Ability to collaborate effectively with peers, stakeholders, and partners across the organization to positively impact business results; knowledge in problem solving methodologies; deep knowledge of ISO 14971. Knowledge of ISO 13485, MDR (2017/745) and 21 CFR 820
Experience in complaint management a plus
Languages: Mandatory English management for Business (written and oral) French or German are a plus.
Technical Skills:
ISO 14971 Risk Management
Post-Market Surveillance (PMS)
FMEA / Risk Analysis Tools
Regulatory Compliance (MDR / 21 CFR 820)
Design Controls & DHF Management
Soft Skills:
The salary range for this position is:
$90.000,00 - $130.000,00
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the .
