Medical Device Quality Engineer (Sustaining Engineering)
Regeneron
Full-time
Remote friendly (East Greenbush, NY)
United States
Operations
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Role Summary
We are seeking a Quality Engineer to join the Medical Device Sustaining Engineering QA team. The role provides Quality Assurance oversight and ensures compliance in supporting combination device development lifecycles. A typical day includes reviewing design and development paperwork for regulatory compliance, ensuring accurate justification of statistical analysis and hypothesis testing, reviewing technical reports and documents for Design History Files, and participating in device risk management activities.
Responsibilities
- 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
Qualifications
- Associate Quality Engineer: 0-2 years (related internship preferred)
- Quality Engineer: 2+ years
- Level is determined based on qualifications relevant to the role
Education
- Bachelor’s degree in Engineering (engineering subject area)