Quality Engineer, Medical Devices; NPD
Job in
Pleasanton, Alameda County, California, 94566, USA
Listed on 2026-07-22
Listing for:
Calyxo, Inc.
Full Time
position Listed on 2026-07-22
Job specializations:
-
Quality Assurance - QA/QC
Quality Engineering, Regulatory Compliance Specialist -
Engineering
Quality Engineering, Regulatory Compliance Specialist
Job Description & How to Apply Below
Calyxo, Inc. in Pleasanton, CA seeks a Staff Quality Engineer to lead design quality across new product development.
You will ensure design controls, risk management, and regulatory readiness for Class‑II medical devices, collaborating with R&D, Regulatory Affairs, and Manufacturing to embed quality throughout lifecycle. The role requires 10–12+ years in medical device quality, strong ISO/IEC knowledge, and a hands‑on approach to V&V, FMEA, and design transfer.
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