Senior Quality Assurance Engineer/Specialist – Supporting Product Install

ViewRay   •  

Virtual / Travel

Industry: Healthcare

  •  

5 - 7 years

Posted 44 days ago

Job Summary

This Quality Assurance Engineer/Specialist will be entirely dedicated to support the MRIdian installation process. This includes Design History Record, Supplier Quality and NCR management. In addition, this position needs to be flexible with travel needs. There is the possibility of having to spend significant time at the hospital during product installation. In this position, team work is critical. This individual will work heavily with the Install, Service and Engineering team and is expected to help create a productive team environment. This individual will be responsible for producing and reviewing documentation to ensure a high level of quality. Driving continuous improvement projects is expected to ensure continued world class documentation as the regulatory environment changes.

This position will report to the Director of Quality

Responsibilities:

• Be a strong cross-functional partner with the Install, Service and Engineering team providing clear and productive guidance on Quality System requirements

• Produce high quality documentation that meets regulatory requirements

• Be a liaison with the office-based Quality team

• Manage Design History Records

• Manage Nonconforming Materials and their records

• Manage Deviations and their records

• Manage Supplier Quality issues upon device installation

Education, Experience, Skills:

• Bachelor's degree in Engineering or Science

• A minimum of 5 years of experience in medical device quality assurance or engineering

• Medical device and related quality system industry experience required

• Knowledge of capital equipment from a Quality System perspective