Quality Systems Analyst

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

• Position: Quality Data Management Analyst
• Location: Burlington, MA (Onsite)
• Employment Type: Contract (W2)
• Pay Rate: $53/hr on W2

• Job Summary
• We are seeking a Quality Data Management Analyst/Quality Systems Analyst to support the governance, integrity, standardization, and lifecycle management of data used across Quality and GxP-regulated business processes.
• The ideal candidate will have experience working with Quality Systems, GxP applications, data governance, data quality, data integrity, analytics, and regulated systems. This role will collaborate closely with Quality, Regulatory Affairs, Manufacturing, Supply Chain, Digital Quality, Computer System Validation (CSV), IT, and other cross-functional teams.
• The position will help ensure Quality data is accurate, complete, reliable, traceable, and fit for intended use while supporting regulatory compliance, reporting, analytics, and quality decision-making.

• Key Responsibilities
• Support implementation and maintenance of Quality data governance frameworks, including data standards, business rules, metadata definitions, ownership, and lifecycle controls.
• Maintain data dictionaries, data maps, data lineage documentation, and controlled definitions supporting Quality metrics, dashboards, and reports.
• Monitor data quality across GxP software applications to identify inconsistencies, duplicates, missing data, inaccuracies, and potential data integrity issues.
• Perform data assessments, reconciliation, cleansing, and trend analysis to improve data reliability and usability.
• Investigate data discrepancies, support root cause analysis, and assist with corrective and preventive actions.
• Promote ALCOA+ data integrity principles across Quality systems, reports, data extracts, and analytical outputs.
• Support enterprise GxP applications including eQMS, ERP, PLM, LIMS, document management, training management, and complaint handling systems.
• Partner with System Owners, Business Process Owners, CSV, Digital Quality, and IT teams during system implementations, upgrades, migrations, integrations, and periodic reviews.
• Assist with User Acceptance Testing (UAT), data migration verification, data validation, and assessment of system changes impacting data quality.
• Support Quality reporting, dashboards, metrics, Management Review, Quality Review, complaint trending, CAPA monitoring, and audit reporting.
• Prepare and verify data extracts, reports, evidence packages, and supporting documentation demonstrating data integrity and traceability.
• Facilitate cross-functional alignment of data definitions, ownership, standards, and governance practices.
• Support internal audits, supplier audits, notified body audits, and regulatory inspections involving Quality data and computerized systems.
• Lead or support continuous improvement initiatives focused on data quality, automation, data accessibility, operational efficiency, and data harmonization.
• Leverage automation and emerging technologies, including AI-enabled capabilities where appropriate and controlled, to improve compliance and business performance.
• Ensure activities comply with applicable regulatory, company, quality, and GxP requirements.

• 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.
• Excellent attention to detail and ability to identify data inconsistencies and trends.
• Ability to collaborate with cross-functional stakeholders and communicate technical/data findings effectively.

• Preferred Qualifications
• Experience supporting software implementations, data migrations, integrations, validation activities, system upgrades, or periodic reviews.
• Experience with eQMS, ERP, PLM, LIMS, training management, document management, complaint, or CAPA systems.
• Knowledge of FDA requirements, ISO 13485, EU MDR, 21 CFR Part 11, EU Annex 11, and ALCOA+.
• Experience with Power BI, Tableau, Google Cloud Platform, or similar reporting/analytics platforms.
• Experience in medical devices, pharmaceutical, biotechnology, or other GxP-regulated environments.
• Experience with Computer System Validation (CSV), UAT, data migration validation, and change control.

• About Trident Consulting
• Trident Consulting is an award-winning staffing and consulting firm headquartered in San Ramon, CA. Since 2005, we’ve partnered with Fortune 500 and high-growth companies to deliver high-quality talent across technology, engineering, business operations, and professional services.

We specialize in contract, contract-to-hire, and direct hire placements, supporting roles across IT, data & analytics, cloud, cybersecurity, finance & accounting, HR, operations, and more. With a strong focus on hard-to-fill and niche positions, our global recruiting engine enables us to deliver speed, quality, and scale.