Unknown Company

Lead Quality Engineer, Medical Devices (QSR/ISO)

hayward, ca • Posted 2 weeks ago
Onsite Full Time Design & Development

Pulse Biosciences in Hayward, CA seeks a Senior Quality Engineer to lead QSR/ISO 13485 quality systems for CellFX medical devices. You will guide design controls, risk management, and validation activities across R&D, manufacturing, and regulatory teams, ensuring compliance with FDA and international standards.

You will manage traceability, biocompatibility, sterilization validation, CAPA, and regulatory submissions, collaborating across departments to support audits and product launches.

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Lead Quality Engineer, Medical Devices (QSR/ISO) in hayward at Unknown Company

This position is listed as full time and onsite.

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