Medical Device Quality Engineer (Sustaining Engineering)

Role Summary

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.

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

• Required: Bachelor’s degree in an Engineering subject area
• Experience by level:
  • Associate Quality Engineer: 0-2 years (related internship preferred)
  • Quality Engineer: 2+ years

Skills

• Knowledge of the combination device development process
• Experience with device risk management activities
• Quality mindset

Education

• Bachelor’s degree in an Engineering subject area