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Job Title : Quality Engineering Analyst – Tracking & Trending

Location: Alameda, CA

Rate: $55/hr W2 - No Benefits Provided

Contract: 12 Months

Schedule: 8:00 AM – 5:00 PM

Category: Quality

Job Summary

Seeking a Quality Engineering Analyst with 2–3 years of experience in a medical device, pharmaceutical, or FDA/ISO-regulated environment. The role will focus on complaint tracking, quality data analysis, trending investigations, root cause analysis, and CAPA support.

Key Responsibilities

• Manage and maintain complaint tracking, reporting, and trending systems.
• Analyze medical/non-medical complaints and quality data to identify trends, risks, and potential product/process issues.
• Support root cause investigations, CAPA, and continuous improvement activities.
• Review manufacturing, shipping, equipment, validation, testing, inspection, stability, SPC, training, and product data to determine potential causes of quality issues.
• Determine the appropriate level and depth of investigation based on risk and nonconformance.
• Develop reports, dashboards, and data visualizations for quality metrics and trends.
• Collaborate with Quality, Operations, Manufacturing, Engineering, and R&D teams.
• Document investigation findings and support FDA and ISO quality-system compliance.

Required Skills

• 2–3 years of experience in Medical Device, Pharmaceutical, or FDA/ISO-regulated environment
• Complaint Handling & Complaint Trending
• Quality Data Analysis
• CAPA & Root Cause Investigation
• FDA/ISO Quality Systems
• Advanced Microsoft Excel
• Quality/Complaint Management Databases
• Strong analytical and problem-solving skills

Preferred Skills

• JMP
• SQL
• Power BI
• Python
• Dashboard Development & Data Visualization
• ASQ Certified Quality Engineer (CQE)

Education

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