Join Sanofi as a Digital Device Quality Engineering Lead, where you will ensure the highest standards of quality and compliance for our innovative SaMD products. You will drive quality strategies and collaborate with diverse teams to enhance patient experiences and meet regulatory requirements.
Key Responsibilities
Lead quality assurance efforts for Software as Medical Device (SaMD) products
Drive quality strategy in various therapeutic areas and markets
Ensure compliance with regulatory standards and guidelines
Manage risk management activities according to ISO 14971
Collaborate with cross-functional teams to enhance product quality
Required Qualifications
Bachelor’s degree in a relevant field (engineering or life sciences)
4+ years’ experience in medical device product development focused on quality engineering
Relevant experience in risk management for medical devices
Knowledge of Quality System standards (21 CFR 820, ISO 13485, IEC 62304, ISO 14971)
Business fluent in English (written and oral)
Preferred Qualifications
Master’s degree in engineering or life sciences
Strong leadership, communication and presentation skills
1-2 years of supplier management experience
Knowledge of safety and cybersecurity risk management for medical devices
Experience in Agile development principles
Benefits & Perks
High-quality healthcarePrevention and wellness programsAt least 14 weeks’ gender-neutral parental leave