"Alerted.org

**Job title** : Senior Quality Engineer

**Location:** 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 Senior Quality Engineer drives 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 Senior Quality Engineer ensures 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.

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:

New Product Development and Design Change Projects

+ 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.

Manufacturing Technology Support

+ 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.

+ Ensure the implementation of the device quality control plans in processes including IPC and QC Testing at sites & CMOs. This also includes implementation of defect catalogue and method transfer across the site’s network.

Critical Manufacturing or supplier related device issues

+ Lead major investigations, and product complaint trends to determine root cause, and ensure corrective actions are identified and implemented to prevent recurrence.

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.

+ 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.

Change Controls

+ 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.

Provide mentoring support to Quality Engineers, as instructed by the Manager.

About You

Requirements

Education:

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

Experience:

+ 3+ years of medical device industry experience

+ Experience in Medical Devices and/ or Drug Device Combination product development (e.g. ISO11608, ISO10993, ISO60601, ISO11040), experience in IEC 62304 is a plus

**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

+ Knowledge of ISO 13485, ISO 14971, MDR (2017/745) and 21 CFR 820

+ Certified Quality Engineering – ASQ certification preferred (CQE)

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

\#LI-Onsite

\#vhd

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.

_North America Applicants Only_

The salary range for this position is:

$108,750.00 - $157,083.33

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK (https://benefits.sanofiusallwell.com/fleet/public/index/ba511bf8-5c32-4828-9861-ab985fffab90/?cid=sanofi) .

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)