Quality Engineering Analyst

Title: Quality Engineering AnalystLocation: Alameda, CADuration: 12 Months100% OnsiteSummaryOur 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.Experience Required2 to 3 years of experience in a:Medical device industry (preferred)Pharmaceutical industryFDA and/or ISO regulated environmentRequired EducationBachelor's Degree in:Biomedical Engineering, orRelated Engineering DisciplinePreferred CertificationsASQ Certified Quality Engineer (CQE) or equivalent certification preferredRequired Technical SkillsCandidates should possess experience in the following areas:Quality data analysis and trending investigationsComplaint handling and complaint trend analysisCAPA support and root cause investigation methodologiesQuality systems within FDA-regulated environmentsData analysis and reporting using Excel and related analytics toolsCross-functional collaboration with Quality, Operations, Manufacturing, and R&D teamsPreferred QualificationsStrong preference for candidates with experience in:JMPAdvanced Microsoft ExcelSQL querying and data analysisPower BIBasic to intermediate Python programmingQuality and complaint management databasesDashboard development and data visualizationKey ResponsibilitiesPerform 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.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.Consultants Eligible Benefits Upon Waiting PeriodMedical and Prescription Drug PlansDental PlanVision PlanHealth Savings Account (for High-Deductible Health Plans)Flexible Spending Accounts (Health, Limited Purpose, Dependent Care, Commuter Parking and Commuter Transit)Supplemental Life InsuranceShort Term Disability (coverage varies by state)Long Term DisabilityCritical Illness, Hospital coverage, Accident InsuranceMetLife Legal, MetLife ID Fraud, and MetLife Pet Insurance401(k)Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional and branded generic medicines.Working together, Abbott and Talent Solutions partner to deliver top talent for contingent roles at Abbott, building better and healthier lives. Abbott believes all employees are essential to creating life-changing breakthroughs, performing key duties to create life-changing breakthroughs.