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Senior Design Quality Engineer at Caris Life Sciences

Setup
Hybrid
Type
Full-time
Level
Senior

Description

Caris Life Sciences is seeking a Senior Design Quality Engineer to join their team. This role involves supporting Design Controls, risk management activities, and maintaining the Design History File (DHF) to ensure compliance with regulations. The engineer will collaborate with various internal teams like assay development, laboratory operations, regulatory affairs, and quality during the entire product lifecycle. Key responsibilities include developing and updating Design and Development Plans, managing risk assessment files, providing mentorship, reviewing DHF deliverables, handling deviations, supporting design reviews and transfers, assisting with design changes and post-market activities, and participating in process improvements.

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