- As a quality core team member, provide quality engineering lead to the core team accountable for the new product development or design change project.
- Perform Quality Engineering and Assurance tasks in medical devices as well as combination product projects to ensure that Quality-related aspects are regarded sufficiently in detail and timely for new device introductions or design change projects.
- Lead implementation of Design Controls elements per relevant procedures for new product development or design change projects including, but not limited to developing Design Inputs\Outputs, performing risk management activities aligned with ISO14971 Risk Management for Medical Devices according to project phases following internal procedures, processes, and external requirements for product development, Design Development Plan (DDP), planning and execution of Design Verification\Validation Studies and relevant method development and validation studies, conducting Design Reviews and Design Transfer and creation or update of Risk Management files.
- Provide quality engineering support in the development of site validation strategy and plans, execution of process development, characterization, operational and performance qualifications, and overall Process Validations in accordance with established regulations and applicable Sanofi procedures.
- Support Technical Transfer projects of medical devices and combination products. This includes but not limited to Process Transfer, Design Transfer (Design outputs and quality control plans), and Site Network procedures and documentation.
- Lead major investigations, and product complaint trends to determine root cause, and ensure corrective actions are identified and implemented to prevent recurrence.
- 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.
- Perform Impact Assessment of changes (components, products, platforms, and processes) post-design transfer, assessing risk and impact on design controls and manufacturing processes.
- Act as the Single Point of Contact (SPOC) for manufacturing sites of medical devices or combination products for device related Change Controls topics.
- BS/MS degree in Engineering or related science discipline.
- Minimum of 2 years of experience in the medical device or combination products
- Experience in New Product Development and\or Life Cycle Management
- Knowledge of ISO 13485, ISO 14971, MDR (2017/745) and 21 CFR 820
- Basic knowledge of Six Sigma Tools
- An advanced degree is a plus.
- Certified Quality Engineering – ASQ certification preferred (CQE) is a plus
- Six Sigma Green Belt certification is preferred.
- Collaborate effectively with peers, stakeholders, and partners across the organization to positively impact business results.
- Business fluent (written and oral) in English required, French or German a plus.
- 50% Remote working and up to 25% of travel expected.
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Quality Engineer - Cambridge, United States - Sanofi Group
Description
Our Team
The Global Device & 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 & Packaging Unit 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 GQ 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.
Key Accountabilities:
The Quality Engineer will 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. The Quality Engineer 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.
The Quality Engineer are accountable on the following:
New Product Development and Design Change Projects:
Manufacturing Technology Support:
Critical Manufacturing or supplier related device issues:
Continuous Improvement:
Change Controls:
About You
Basic Qualifications:
Preferred Qualifications:
Soft skills :
Languages :
Additional information:
Learn more about Sanofi M&S:
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
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