Senior QA Engineer — Medical Devices Compliance

Mizuhosi; Union City (CA); On-site; USD 136,000 - 156,000; Full time

Job summary

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.

Qualifications

• Bachelor’s degree in science or related field with relevant experience in medical devices.
• Experience with ISO 13485, FDA QMSR, EU MDR and related regulatory requirements.
• Experience in CAPA handling, NCRs, Deviations and audit management.

Responsibilities

• Provide QA input during manufacturing, production and design activities for new products and changes.
• Lead internal audits and manage audit lifecycle (scheduling, reports, responses, closing out).
• Maintain inspection readiness for regulatory and external audits (Notified Bodies, FDA).
• Manage CAPAs, complaints, and drive closure within timelines.
• Develop quality metrics, data tools, and remediation plans for non-conformances.

Skills

QA Engineering

Regulatory Knowledge

Audits

CAPA

Documentation

Statistical Analysis

Change Control

Education

Bachelor’s degree in science or related field

Tools

CAD

Job description

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.