About the role
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 .
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