Principal / Sr. Quality Engineer (Medical Device)

Tarrytown, New York, US
Sep 25, 2018
Required Education
Bachelors Degree
Position Type
Full time
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.

Summary: Provide Quality Assurance guidance and ensure compliance in the support of combination device development life cycles.

Essential Duties and Responsibilities include, but are not limited to, the following:

• Review Design and Development paperwork, records, etc for compliance to internal procedures and regulations.

• Ensure proper justification of statistical analysis and hypothesis testing.

• Review technical repmis as well as documents for Design History Files.

• Participate in device risk management activities including UFMEA, DFMEA, PFMEA.

• Aid in establishing proper statistical controls in development and transfer to manufacturing processes.

• Verity data integrity, electronic data storage and data sheet validations.

• Review and coordinate with QA Validation for all test method and design validations.

• Review activities related to Design Verification and Design Transfer of Medical Devices.

• Ensure work product meets regulations.

• Support scientific, complaint, and test failure investigations.

• Perform data trend analysis, where applicable.

• Participate in Phase Reviews.

• Write Quality Procedures, as applicable.

• Perform Data/Statistical analysis as needed.
Education and Experience:

• Sr. Quality Engineer level - BS in Engineering and 6+ years or MS in Engineering and 4+ year experience in the combination device or medical device industry.

• Principal Quality Engineer level - BS in Engineering and 8+ years or MS in Engineering and 6+ year experience in the combination device or medical device industry.

• CQE preferred.

• Six Sigma Black Belt preferred.

*Level will be determined based on skills and related experience.*

This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.

To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.