Quality Engineer

Job Title : Quality Engineer

Location : Cambridge, MA or Swiftwater, PA

About the Job

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

The Global Quality Medical Device (GQMD) 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 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.

We are an innovative global healthcare company with one purpose : to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main Responsibilities :

Establish and maintain the global device risk management processes.

Perform risk management according to ISO 14971 (risk management planning, hazard and harms list, Risk management reports…) and assists medical device sites in ensuring that risk management is performed in sufficient detail and in a timely manner for new device introductions and regulatory agency inspections.

Ensure that project teams utilize appropriate risk analysis tools to assure that the Risk Management requirements are met.

Develop and deploy appropriate Risk Management training for various internal and external Sanofi functions.

Provide appropriate support to remediation of risk management files.

Provide expertise and guidance to ensure a harmonized approach for all development and lifecycle management programs and perform Risk Management activities aligned with ISO 14971 including the update to Risk Management File based on post-market surveillance.

Partner with other quality, compliance, development, and manufacturing groups to enable transparency, escalation, and action to resolve patient-safety-related issues.

Establish and maintain linkages to other relevant risk management groups within Sanofi (e.g. Quality Risk Management, Technical Committee).

Interface with network sites for device RMF-related topics

Oversee trend outputs of market complaints within the network to identify possible multi-site impacts and implement the required corrective and / or preventive actions. If new risks are identified (failure modes) requiring an update of the risk analyses (pFMEA, dFMEA, use FMEA), notification of the impact to network sites.

Interact with internal and external teams (engineering / product development / regulatory / suppliers) to define the plan, timelines and strategy for development of the Clinical evaluation reports

Support implementation of Design Controls elements per relevant procedures for new product development or design changes including Design History File (DHF) Maintenance

Support Supplier Quality Engineering activities

Support continuous improvement of projects or activities.

Provide quality engineering support for Manufacturing Technology activities (includes but not limited to validation, transfer, supplier selection, and quality control plan)

Perform Impact Assessment of change controls (components, products, platforms, and processes)

About You

Experience : 6 years of relevant experience in medical device industry; relevant experience in in Risk Management; experience in connected devices is highly appreciated.

Soft and technical skills : ability to collaborate effectively with peers, stakeholders, and partners across the organization to positively impact business results; Knowledge in problem solving methodologies; Knowledge of ISO 13485, ISO 14971, MDR (2017 / 745) and 21 CFR 820

Education : BS / MS degree in Engineering or related science discipline. An advanced degree is a plus

Languages : Business fluent (written and oral) in English required, French or German a plus

Why Choose Us?

Bring the miracles of science to life alongside a supportive, future-focused team.

Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.

Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.

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.

GD-SA ​

LI-SA​ ​

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Pursue progress , discover extraordinary

Better is out there. Better medications, better outcomes, better science. But 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. So, let’s 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) !

US and Puerto Rico Residents Only

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; 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.

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)