To ensure a rapid processing of your application, please apply only via the u201cApplyu201d button. Please include a letter of motivation and a current resume with your application. 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 siteu2019s network. Support the design and commissioning of machine/equipment (e.g. molding, assembly and packaging). This includes working with CMOs/suppliers, sitesu2019 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 CMOu2019s 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 doesnu2019t happen without people u2013 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. Letu2019s pursue progress. And letu2019s 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. Watch our ALL IN video (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) ! Pursue _progress_, discover _extraordinary_ Better is out there. Better medications, better outcomes, better science. But progress doesnu2019t happen without people u2013 people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, letu2019s be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) ! Global Terms & Conditions and Data Privacy Statement (https://www.sanofi.com/en/careers/global-terms-and-conditions/) Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi (https://youtu.be/96EwNjb1TLo) As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live. All in for Diversity, Equity and Inclusion at Sanofi - YouTube (http://www.youtube.com/watch?v=SkpDBZ-CJKw&t=2s)