Medical Device Quality Engineer (Sustaining Engineering)

Role Summary

Medical Device Quality Engineer (Sustaining Engineering) – This position provides Quality Assurance oversight and ensures 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

• Bachelor‚Äôs degree in an Engineering subject area
• Associate Quality Engineer: 0-2 years (related internship preferred) or Quality Engineer: 2+ years in combination device or medical device industry

Skills

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

Education

• Bachelor‚Äôs degree in Engineering or related field

Additional Requirements

• Note: Salary range listed is for U.S.-based positions; other locations to be discussed with recruiter. Background checks may be conducted as part of the recruitment process.