Principal Quality Engineer: Design Controls Devices
Job in
Scottsdale, Maricopa County, Arizona, 85261, USA
Listed on 2026-07-23
Listing for:
Ascent360
Full Time
position Listed on 2026-07-23
Job specializations:
-
Engineering
Quality Engineering, Biomedical Engineer, Regulatory Compliance Specialist
Job Description & How to Apply Below
Regenesis Biomedical Inc seeks a Principal Quality Engineer to lead the Quality Management System with a focus on Design Controls for Class II medical devices. The role spans the full product lifecycle from development through commercialization, ensuring compliance with FDA QMSR, ISO 13485, and ISO 14971.
You will drive design transfer, process validation, and manufacturing quality while mentoring engineers and advancing CAPA and risk management efforts across functions.
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