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 consistency (e.g. DHF/DMR, Alliance impact etc.) for inter-site change controls between GDPU and network sites
- Act as the Single Point of Contact (SPOC) for manufacturing sites of medical devices or combination products for device related Change Controls topics and operational knowledge transfer.
- Provide mentoring support to Quality Engineers, as instructed by the Manager.
About you:
- Experience: 5+ years of medical device industry experience
- Soft skills:Collaborate effectively with peers, stakeholders, and partners across the organization to positively impact business results.
- Technical skills:
- Knowledge of Six Sigma Tools or Six Sigma Green Belt certification is highly preferred.
- Excellent knowledge of relevant regulatory requirements related to medical devices, drug-device-combination products as per e.g. 21 CFR 820, ISO13485, EU Medical Device Regulation, ISO14971, ISO10993.
- Certified Quality Engineering - ASQ certification preferred (CQE)
- Good communication and presentation skills toward colleagues and international external partners
- Good knowledge of project management and problem-solving/troubleshooting methodologies (GPS) are an advantage
- Education:BS/MS degree in Engineering or related science discipline. An advanced degree is a plus.
- Languages: Business fluent in English (written and oral), any other language as a plus
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Diversity und Inklusion sind in den Grundwerten von Sanofi verankert und spiegeln sich in unserer Arbeitsweise wider. Wir respektieren die Vielfalt unserer Belegschaft in Hinsicht auf ihre Herkunft, Erfahrungen und Lebensweisen. Wir erkennen die Bereicherung, die diese Vielfalt birgt, und fördern Inklusion sowie eine Arbeitsumgebung, in der diese Unterschiede sich weiter entwickeln können, zur Stärkung des Lebens unserer Mitarbeiter, Patienten und Kunden.
