Career Opportunities

Sr. Quality Engineer (Medical Device)

Posted on: Friday, July 13, 2018
Organization: Regeneron
Location: Rensselaer, NY
Description:
Position Summary
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.
Requirements:

Education and Experience:

• For Quality Engineer level - BS in Engineering and 4+ years or MS in Engineering and 2+ year experience in the combination device or medical device industry.

• For 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.

• For 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.

Apply Now

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