Quality Engineering Analyst
Intellectt INC
Hiring: Quality Engineering Analyst Tracking & Trending
Location: Alameda, CA On-site
We are looking for a Quality Engineering Analyst to support complaint handling, quality data analysis, trending, and root cause investigationh within a regulated medical device environment.
Key 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
Requirements:
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
Vacancy posted 1 day ago
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