Medical Device Sr. Lifecycle QE
Our client is a large medical device manufacturer. They are in need of a quality engineer to come in and support day to day responsibilities as they grow and integrate.
This consultant will be responsible for helping with our clients day to day quality engineering responsibilities. They will need to be a senior level quality engineer with an advanced statistics background.
They must know how to set up tests/experiments, while ensuring that quality is being held. Alongside statistics, they will need to understand sampling plans and how to create/develop them. They will also be supporting risk management documentation, so they need to have a background in FMEAs.
Since this documentation will be a large part of their assignment, they must understand GDP (good documentation practices). They will be running product failure investigations as well. They will also need a background in non-conformance investigations, as well as CAPA investigation and review. They will also be reviewing and approving protocols and reports from the engineering team. This will include engineering studies, input output matrix, customer level requirements, product level requirements, design changes, and after product launch process changes.
Statistics and Sampling Plans
Risk Management (FMEA)
CAPA and Non-conformance Investigations
Job Type: Contract