Data Quality Analyst

Trident Consulting is seeking a "Quality Data Management Analyst” for one of our client in "Aliso Viejo, CA". A global leader in business and technology services

• Job Title: Quality Data Management Analyst
• Job Function: Quality / Data Management / Data Analytics
• Industry: Medical Device / GxP-Regulated Environment
• Experience: 3+ Years
• Location: Glaukos – Aliso Viejo, CA

• Job Summary
• The Quality Data Management Analyst supports the governance, integrity, standardization, and lifecycle management of data across Quality and GxP-regulated business processes. This role ensures Quality data is accurate, complete, reliable, traceable, and fit for intended use while supporting regulatory compliance, reporting, analytics, and quality decision-making.
• The position collaborates with Quality, Regulatory Affairs, Manufacturing, Supply Chain, Digital Quality, CSV, IT/GTS, and other stakeholders to establish data standards, improve data quality, and support enterprise GxP systems.
• Key Responsibilities
• Support Quality data governance frameworks, including data standards, business rules, metadata, ownership, and lifecycle controls.
• Maintain data dictionaries, data maps, data lineage, and controlled data definitions.
• Monitor GxP application data for inconsistencies, inaccuracies, duplicates, missing information, and data integrity concerns.
• Perform data assessments, reconciliation, cleansing, and trend analysis.
• Investigate data discrepancies and support root cause analysis and CAPA activities.
• Promote ALCOA+ data integrity principles across Quality systems and analytical outputs.
• Support GxP systems including eQMS, ERP, PLM, LIMS, document management, training management, and complaint/CAPA systems.
• Partner with System Owners, Business Process Owners, CSV, Digital Quality, and IT on system implementations, upgrades, migrations, integrations, and periodic reviews.
• Support UAT, data migration verification, data validation, and system change assessments.
• Prepare and verify Quality data for dashboards, metrics, Management Review, Quality Review, complaint trending, CAPA monitoring, and audit reporting.
• Support internal audits, supplier audits, notified body audits, and regulatory inspections involving Quality data and electronic records.
• Prepare data extracts, reports, evidence packages, and documentation supporting data integrity and traceability.
• Lead or support continuous improvement initiatives involving data quality, automation, data accessibility, and data harmonization.
• Leverage automation and AI-enabled tools where appropriate and compliant.
• Ensure compliance with applicable regulatory, company, and quality requirements.
• Perform other quality-related duties as assigned.
• Required Qualifications
• 3+ years of experience in Quality Systems, Data Management, Data Analytics, Regulatory Affairs, Information Management, or a related function within a regulated industry.
• Experience working with GxP software applications and regulated data.
• Experience with data analysis, reconciliation, cleansing, issue investigation, and data quality improvement.
• Knowledge of data governance, master data management, data lifecycle management, and data integrity principles.
• Strong analytical, organizational, documentation, and problem-solving skills.
• High attention to detail and accuracy.
• Ability to identify trends, communicate findings, and develop practical solutions.
• Preferred Qualifications
• Experience supporting software implementations, data migrations, integrations, validation, periodic reviews, or regulated system changes.
• Familiarity with FDA requirements, ISO 13485, EU MDR, 21 CFR Part 11, EU Annex 11, and ALCOA+.
• Experience with reporting and visualization tools such as Power BI, Tableau, or Google Cloud Platform.
• Experience in medical device, pharmaceutical, biotechnology, or other GxP-regulated environments.
• Experience working with Quality systems such as eQMS, LIMS, ERP, PLM, CAPA, Complaint Management, Training Management, and Document Management.