Quality Engineering Analyst

Intellectt Inc; California (MO); On-site; USD 90,000 - 120,000; Full time

Job summary

Intellectt Inc. is seeking a data-driven professional to track and trend complaints, evaluate medical and non-medical issues, and support CAPA activities in a regulated environment. The role focuses on analyzing quality data, developing reports and dashboards, and collaborating with Quality, Operations, Manufacturing and R&D teams.

The candidate should have a Biomedical Engineering or related degree, strong Excel and reporting skills, and experience with quality systems and complaint databases.

Qualifications

• Bachelor’s degree in Biomedical Engineering, Engineering, or related field.
• Experience with quality data analysis and complaint trending.
• Knowledge of CAPA and root cause investigation.
• Proficient in Excel and data reporting.
• Experience with quality systems and complaint databases.
• Strong analytical, problem-solving, and communication skills.

Responsibilities

• Track and trend complaints, quality data, and emerging product/process issues.
• Evaluate medical and non-medical complaints and stability investigation requests.
• Support root cause investigations and CAPA activities.
• Review manufacturing, shipping, validation, testing, inspection, SPC, and quality trend data.
• Analyze data to identify risks, non-conformances, and recurring quality issues.
• Develop reports, dashboards, and data visualizations.
• Maintain complaint tracking and follow-up systems.
• Collaborate with Quality, Operations, Manufacturing, and R&D teams.
• Document investigation findings and support FDA/ISO quality system compliance.
• Present data-driven findings and recommendations to stakeholders.
• Experience in medical device, pharmaceutical, or FDA/ISO-regulated environments

Education

Bachelor’s Degree in Biomedical Engineering, Engineering, or related field

Tools

Microsoft Excel

Job description

• Track and trend complaints, quality data, and emerging product/process issues
• Evaluate medical and non-medical complaints and stability investigation requests
• Support root cause investigations and CAPA activities
• Review manufacturing, shipping, validation, testing, inspection, SPC, and quality trend data
• Analyze data to identify risks, non-conformances, and recurring quality issues
• Develop reports, dashboards, and data visualizations
• Maintain complaint tracking and follow-up systems
• Collaborate with Quality, Operations, Manufacturing, and R&D teams
• Document investigation findings and support FDA/ISO quality system compliance
• Present data-driven findings and recommendations to stakeholders
• Experience in medical device, pharmaceutical, or FDA/ISO-regulated environments
• Bachelor’s Degree in Biomedical Engineering, Engineering, or related field
• Experience with quality data analysis and complaint trending
• Knowledge of CAPA and root cause investigation
• Strong Microsoft Excel and reporting skills
• Experience with quality systems and complaint databases
• Strong analytical, problem-solving, and communication skills