Quality Engineering Analyst

Job Title: Quality Engineering AnalystLocation: Almeda, CASummary: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.