Software Quality Engineer - MedTech CSA & Validation
Job in
Cypress, Orange County, California, 90630, USA
Listed on 2026-07-10
Listing for:
El Camino Health
Full Time
position Listed on 2026-07-10
Job specializations:
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist, Quality Engineering
Job Description & How to Apply Below
iRhythm Technologies, Inc. seeks a Staff Software Quality Engineer for Non-Product Software (NPS) to define CSA strategy and validation master plans for software supporting medical device development and manufacturing.
You will lead risk-based validation, ensure 21 CFR Part 11 and ISO 13485 compliance, and drive audits with Manufacturing, IT, Dev Ops and R&D teams. Hybrid role with on-site presence in Orange County; strong regulatory expertise required.
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