About this role
We are currently looking to fill a Quality Engineer position on the Medical Device Sustaining Engineering QA team. This position will provide Quality Assurance oversight and ensure compliance in the support of combination device development life cycles.
In this role, a typical day might include the following:
Reviewing design and development paperwork and records for compliance to internal procedures and regulations
Ensuring accurate justification of statistical analysis and hypothesis testing
Reviewing technical reports as well as documents for Design History Files
Participating in device risk management activities including UFMEA, DFMEA, PFMEA
Aiding in establishing statistical controls in development and transfer to manufacturing processes
Reviewing and coordinating with QA Validation for all test method and design validations
Reviewing activities related to Design Verification and Design Transfer of Medical Devices
Ensuring work product meets regulations
Supporting scientific, complaint, and test failure investigations
Performing data trend analysis, participating in Phase Reviews, writing Quality Procedures, performing data/statistical analysis
This role might be for you if:
You have knowledge of the combination device development process
You have experience with device risk management activities
You have a quality mind-set
To be considered for this role you must hold a Bachelor’s degree in an Engineering subject area and the following amount of work experience in combination device or medical device industry for each level:
Associate Quality Engineer: 0-2 years (related internship preferred)
Quality Engineer: 2+ years
Level is determined based on qualifications relevant to the role.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries’ specific benefits, please speak to your recruiter.
Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location.
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
Salary Range (annually)
Other facts
About Regeneron Pharmaceuticals
At Regeneron we believe that when the right idea finds the right team, powerful change is possible. As we work across our expanding global network to invent, develop and commercialize life-transforming medicines for people with serious diseases, we’re establishing new ways to think about science, manufacturing and commercialization. And new ways to think about health. Connect with us so we can learn more about you, and you can learn more about our biopharmaceutical medicines. And join us, as we build a future we believe in.
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What you'll do
- The Quality Engineer will provide Quality Assurance oversight and ensure compliance in the support of combination device development life cycles. Responsibilities include reviewing design paperwork, participating in risk management activities, and supporting investigations related to quality issues.
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