Quality Engineering Analyst

Location: Alameda, CA 94502 – Onsite
Duration: 12-month contract with possible extension
Schedule: 8:00 AM – 5:00 PM, Monday – Friday

About the Role

Our client is seeking a Quality Engineering Analyst (Tracking & Trending) to support complaint and quality data analysis activities within a regulated medical device environment. This role is responsible for performing trending investigations, analyzing complaint data, identifying potential product and process issues, supporting root cause investigations, and driving continuous improvement initiatives. The individual will collaborate closely with Quality, Operations, Manufacturing, and R&D teams while ensuring compliance with FDA and ISO quality system requirements.

Responsibilities

• Perform complaint tracking and trending activities using quality databases and analytical tools.
• Analyze complaint, CAPA, and quality system data to identify trends, risks, and emerging issues.
• Support root cause investigations and CAPA activities.
• Create dashboards, reports, and data visualizations utilizing Excel, Power BI, JMP, SQL, and Python.
• Partner with Quality, Operations, Manufacturing, and R&D teams to investigate product and process concerns.
• Document investigative findings and support regulatory compliance requirements.
• Assist with continuous improvement initiatives related to complaint handling and quality trending processes.
• Present findings, recommendations, and data-driven insights to stakeholders.

Requirements

• 2 to 3 years of experience in a medical device industry (preferred), pharmaceutical industry, or FDA and/or ISO regulated environment.
• Bachelor’s Degree in Biomedical Engineering or related engineering discipline.
• Experience in quality data analysis and trending investigations.
• Complaint handling and complaint trend analysis.
• CAPA support and root cause investigation methodologies.
• Quality systems within FDA-regulated environments.
• Data analysis and reporting using Excel and related analytics tools.
• Cross-functional collaboration with Quality, Operations, Manufacturing, and R&D teams.

Preferred Qualifications

• ASQ Certified Quality Engineer (CQE) or equivalent certification.
• Experience with JMP, advanced Microsoft Excel, SQL querying and data analysis, Power BI.
• Basic to intermediate Python programming.
• Quality and complaint management databases.
• Dashboard development and data visualization.