QA Engineer - Medical Devices (ISO 13485)

Suna Solutions; Torrance (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

Suna Solutions in Torrance, CA, is seeking a Quality Assurance Engineer to ensure the quality and compliance of advanced video and audio hardware systems. You will collaborate with Engineering and Production teams to verify product performance and drive continuous improvement initiatives.

The ideal candidate will have strong technical troubleshooting capabilities, experience in ISO-regulated environments, and a passion for quality excellence, with working knowledge of ISO 13485 and ISO 9001.

Qualifications

• Bachelor's degree in a related engineering discipline.
• 5+ years of quality assurance or quality control experience.
• Experience with ISO 13485 and ISO 9001 environments.
• Experience with video/audio hardware systems preferred.

Responsibilities

• Own QA and QC processes.
• Perform verification, validation, and qualification testing.
• Conduct product inspections and failure analysis.
• Operate lab equipment including oscilloscopes, signal analyzers, and signal generators.
• Support quality planning, scheduling and resource allocation.
• Lead investigations and corrective actions.
• Conduct internal and supplier audits.
• Support ISO 13485 and ISO 9001 compliance activities.
• Develop and maintain quality policies, procedures, and documentation.
• Collaborate with engineering on hardware/software quality concerns.

Skills

Quality Assurance

ISO 13485

Testing & Verification

Lab Equipment

Root Cause Analysis

Education

Bachelor's degree in related engineering

Tools

Oscilloscopes

Signal Analyzers

Signal Generators

Job description

Suna Solutions in Torrance, CA, is seeking a Quality Assurance Engineer to ensure the quality and compliance of advanced video and audio hardware systems. You will collaborate with Engineering and Production teams to verify product performance and drive continuous improvement initiatives.

The ideal candidate will have strong technical troubleshooting capabilities, experience in ISO-regulated environments, and a passion for quality excellence, with working knowledge of ISO 13485 and ISO 9001.