Sr. Quality Engineer (Medical Device)
|Posted on:||Friday, July 13, 2018|
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: