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About the job

Our Team:

Our team belongs to Global Device & Packaging Quality (GDPQ) and has end-to-end accountability for industrialization of drug-device combination products, standalone medical devices, and packaging. It collaborates closely with the Global Device & Packaging Unit (GDPU), various Sanofi sites, other global functions as well as Contract Manufacturing Organizations (CMOs), suppliers and external partners to achieve new product introduction, scale up and efficient product launches as well as capacity extensions and process optimizations during life-cycle. Our team drives standardization and continuous improvement, promotes simplification, and ensures compliance.

Main responsibilities:

As a Quality Engineer you will support Design Control activities for new product development and life-cycle management playing a key role by leading cGMP compliance activities on assigned projects end-to-end. This includes compliance with relevant Sanofi policies and procedures, domestic and international regulations, standards, guidelines and customer requirements.

• Perform quality engineering and assurance tasks for new product introductions and design change projects to ensure that quality-related aspects are regarded sufficiently and timely.
• Provide quality engineering support in the development of site validation strategy and plans as well as support the execution of process development, operational and performance qualifications, and overall process validations in accordance with established regulations and applicable Sanofi procedures.
• Support risk management process throughout the entire product life-cycle.
• Support Technology Transfer projects of medical devices and drug-device-combination products. This includes but not limited to transfer of manufacturing processes, test methods, site network procedures and documentation as well as Design Transfer (design outputs and quality control plans).
• Ensure the implementation of the device quality control plans in processes including IPC and QC testing at sites and CMOs. This also includes method transfer across the site's network.
• Support the design and commissioning of machine/equipment (e.g. molding, assembly and packaging). This includes working with CMOs/suppliers, sites' operational and quality teams, technical compliance and central engineering.
• Support CMO/supplier selection and qualification for the manufacturing of device components. This includes development of the quality agreements and support of audits, qualification and validation activities, this also includes maintaining a QA to QA contact relationship with the CMO's when it comes to projects and industrialization support.
• Contribute as SME to Sanofi internal audits, customer audits and health authority inspections.
• Support continuous improvement projects or activities which may include product or process improvements in collaboration with other platform quality engineers or functions.
• Perform Impact Assessment of changes (components, products, platforms, and processes) post-design transfer, assessing risk and impact on design controls and manufacturing processes.

About you

• Experience: Experience in the medical device and/or pharmaceutical industry; Experience in medical devices and/ or drug-device combination product development and/or life-cycle management
• Soft and technical skills: Collaborate effectively with peers, stakeholders, and partners across the organization to positively impact business results; Knowledge of ISO 13485, ISO 14971, MDR (2017/745) and 21 CFR 820
• Education: Bachelors/Masters degree in Engineering or related science discipline. An advanced degree is a plus.
• Languages: Competency in English language to support role responsibilities; French or German a plus

Pursue Progress . Discover Extraordinary .

Progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let's pursue progress. And let's discover extraordinary together.

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

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