Our client is seeking a Senior Quality Engineer for a 6-12 month contract. The Quality Engineer will provide quality oversight and quality support for the client’s medical device and combination device products. This consultant will provide oversight over internal manufacturing activities and be involved in activities such as risk management, vendor selection, and validation activities to comply with FDA requirements. Lead risk management activities in compliance with ISO 14971. Assist in responses to regulatory questions.
- Skills: Quality oversight, ISO 13485, ISO 14971, risk management, validation, medical device, combo device
- Education: B.S in a life sciences field
Hybrid – Providence, RI: Quality Engineer (Medical Device) (230899)