Quality Engineering Analyst

Intellectt Inc; Alameda (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

Intellectt Inc is seeking a Quality Engineering Analyst to manage complaint tracking, trending, and investigation activities in a regulated medical device or pharmaceutical environment. The role analyzes complaint and quality data, identifies trends and root causes, supports CAPA activities, and ensures compliance with FDA and ISO quality system requirements.

The candidate will maintain complaint tracking, analyze data across CAPA, stability, manufacturing, and quality systems, and develop

Qualifications

• Bachelor's degree in Science, Biomedical Engineering, or related field.
• 2–3 years of experience in medical device, pharmaceutical, or FDA/ISO regulated environments.
• Experience with complaint handling, quality trending, root cause analysis, and CAPA processes.
• Strong analytical, reporting, and cross-functional communication skills.

Responsibilities

• Maintain complaint tracking and reporting systems.
• Analyze complaint, CAPA, stability, manufacturing, testing, and quality system data to identify trends and risks.
• Conduct and support root cause investigations, determining the scope based on risk and nonconformance impact.
• Develop reports, dashboards, and data visualizations using Excel and other analytics tools.
• Collaborate with Quality, Manufacturing, Operations, Engineering, and R&D teams.
• Ensure compliance with FDA Quality System regulations and ISO standards.
• Document findings and support continuous improvement initiatives.

Skills

Analytical skills

Reporting skills

Cross-functional communication

Education

Bachelor's degree in Science or Biomedical Engineering

Tools

Excel

Job description

Seeking a Quality Engineering Analyst to manage complaint tracking, trending, and investigation activities in a regulated medical device or pharmaceutical environment. This role analyzes complaint and quality data, identifies trends and root causes, supports CAPA activities, and ensures compliance with FDA and ISO quality system requirements.

Key Responsibilities:

• Maintain complaint tracking and reporting systems.
• Analyze complaint, CAPA, stability, manufacturing, testing, and quality system data to identify trends and risks.
• Conduct and support root cause investigations, determining the scope based on risk and nonconformance impact.
• Develop reports, dashboards, and data visualizations using Excel and other analytics tools.
• Collaborate with Quality, Manufacturing, Operations, Engineering, and R&D teams.
• Ensure compliance with FDA Quality System regulations and ISO standards.
• Document findings and support continuous improvement initiatives.

Requirements:

• Bachelor's degree in Science, Biomedical Engineering, or a related engineering discipline.
• 2-3 years of experience in medical device, pharmaceutical, or FDA/ISO regulated environments.
• Experience with complaint handling, quality trending, root cause analysis, and CAPA processes.
• Strong analytical, reporting, and cross-functional communication skills.