Quality Test Engineer

About the role

We are seeking a Quality Test Engineer to investigate customer complaints, identify root causes, and implement corrective and preventive actions for medical device products.

Tasks

• Investigate customer complaints related to product design, manufacturing, and testing.
• Perform root cause analysis and support CAPA activities.
• Review and prioritize nonconformances (NCs) and customer complaints.
• Analyze quality data and support continuous improvement initiatives.
• Participate in CAPA trending meetings and internal/external audits.
• Evaluate manufacturing and supplier-related issues involving medical device equipment.

Requirements

• Bachelor's degree in Engineering.
• Minimum 2 years of engineering-related experience.
• Experience with customer complaints, nonconformances (NCs), root cause analysis, and CAPA.
• Ability to read and interpret electrical and mechanical schematics.
• Preferred: Medical device industry experience, especially ENT products.
• Preferred: Experience with electrical testing and multiple medical device products.
• Preferred: Knowledge of ISO 13485, ISO 14971, FDA quality regulations, FMEA, Fault Tree Analysis, and Six Sigma.
• Preferred: Familiarity with Minitab, QI Macros, and quality management systems.

Schedule

• Duration: 6 months, with possible extension and full-time conversion
• Monday–Friday
• On-site

How to apply

• Reach out via direct message or email your resume.

Location

• Irvine, CA