California Quality Engineering Analyst

Job Summary

To support a regulated medical device environment, the contract Quality Engineering Analyst will track complaints, evaluate quality data, and collaborate with cross-functional teams to ensure compliance and improve product quality.

Key responsibilities

• Track and trend complaints and quality data while evaluating medical and non-medical complaints
• Support root cause investigations and CAPA activities, documenting findings for FDA/ISO compliance
• Analyze data to identify risks and develop reports and dashboards for stakeholders

Required qualifications

• Bachelor's Degree in Biomedical Engineering, Engineering, or a related field
• Experience in medical device, pharmaceutical, or FDA/ISO-regulated environments
• Knowledge of CAPA and root cause investigation processes
• Strong skills in Microsoft Excel and quality data analysis
• Experience with quality systems and complaint databases