Medical Device Complaints Analyst

100% ONSITE ALAMEDA CA PAY: $54-$59/hr MUST BE LOCAL TO THE ALAMEDA CA LOCATION REQUIRED: BS in Biomedical Engineering preferred Medical device complaint handling 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 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 Preferred Certifications ASQ Certified Quality Engineer (CQE) Job Description: 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. Key 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. Ideal Candidate Profile The ideal candidate will have: Experience working in a medical device or other highly regulated environment. Strong analytical and problem-solving capabilities. Experience analyzing complaint and quality data. Exposure to CAPA processes and root cause investigations. Ability to communicate technical findings clearly to cross-functional stakeholders. Proficiency with data analytics and reporting tools.