Senior Medical Device Quality Engineer - ISO 13485/IEC 62304
Job in
Alameda, Alameda County, California, 94501, USA
Listed on 2026-08-08
Listing for:
Epia Neuro
Full Time
position Listed on 2026-08-08
Job specializations:
-
Quality Assurance - QA/QC
Quality Engineering, Regulatory Compliance Specialist
Job Description & How to Apply Below
Epia Neuro is seeking a Senior Quality Engineer to help build out the quality function for medical device software and firmware. You will support IEC 62304, ISO 14971, ISO 13485/FDA QMSR compliance throughout the product lifecycle and collaborate with software teams on risk management and design controls.
You will report to the Quality Manager and help stand up robust change control, document review workflows, and audit readiness while growing into more independent authority as the function
#J-18808-LjbffrPosition Requirements
10+ Years
work experience
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