Staff Quality Engineer, Design Quality - Pleasanton, CA

Calyxo(1 month ago)

HybridFull TimeSenior$165,000 - $195,000Quality Assurance

About this role

The Staff Quality Engineer at Calyxo ensures Class-II medical devices meet regulatory and quality expectations across the product development lifecycle, supporting product commercialization. The role is part of the New Product Development team and partners with cross-functional teams to maintain a culture of quality, compliance, and continuous improvement. The position is based in Pleasanton, CA with a hybrid onsite/remote schedule.

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Required Skills

Design Controls
Risk Management
Design V&V
Software Validation
Design Reviews
Traceability
Test Validation
Design Transfer
Regulatory Submissions
Sterilization

+12 more

Qualifications

Bachelor's Degree in Engineering
ASQ CQE
ASQ CSQE
Six Sigma Black Belt

About Calyxo

calyxoinc.com

Calyxo, Inc. develops medical technology to improve care for patients with kidney stones. Its flagship CVAC System is described as the world’s first all‑in‑one, integrated kidney stone treatment platform, designed to simplify and enhance stone management. The company aims to redefine stone care for patients and providers by offering a compact, clinical solution that improves treatment efficiency and patient experience.