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Senior QA Engineer — Medical Devices Compliance

Job in Union City, Alameda County, California, 94587, USA
Listing for: Mizuhosi
Full Time position
Listed on 2026-07-31
Job specializations:
  • Quality Assurance - QA/QC
    Quality Engineering
Salary/Wage Range or Industry Benchmark: 136000 - 156000 USD Yearly USD 136000.00 156000.00 YEAR
Job Description & How to Apply Below

Mizuho OSI is seeking a QA Engineer to lead quality assurance activities and ensure compliance with FDA QMSR, ISO 13485, and EU MDR for capital equipment and accessories. The role supports manufacturing, design validation, and continuous improvement initiatives across cross-functional teams.

Responsibilities include audits, CAPA management, labeling collaboration, documentation for sterilization processes, and maintaining regulatory readiness.

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Position Requirements
10+ Years work experience
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