Quality Systems & Data Analyst

Position Summary

The Quality Systems & Data Analyst is responsible for developing, maintaining, and optimizing the data systems that support complaint handling, RMA tracking, CAPA management, validation records, and ISO 9001 compliance activities.

This role goes beyond data entry and reporting. It owns the structure, integrity, and performance of Quality-related data systems across one or more manufacturing sites.

Key Responsibilities

 Quality Data Architecture & System Development

• Maintain structured databases for RMA, complaints, CAPA, validation, and FAI tracking
• Develop scalable data models supporting multi-site operations
• Configure and optimize QMS software workflows (if applicable)
• Build structured intake and tracking tools for complaint handling
• Ensure traceability and audit-ready record retention

Dashboard & Reporting Development

• Develop automated KPI dashboards (Power BI, Tableau, or equivalent)
• Build SQL-based reporting queries where required
• Maintain trending reports for:
  • RMA rate
  • CAPA aging
  • First Pass Yield (FPY)
  • Cost of Quality (COQ)
  • Audit findings
• Create executive-level and operational-level reports

ISO 9001 System Support

• Maintain controlled documented information in digital systems
• Ensure data integrity aligned to ISO 9001:2015 requirements
• Support internal and external audit preparation
• Maintain audit trails and revision histories

Complaint & CAPA Workflow Management

• Develop and maintain electronic workflow systems for:
  • 8D investigations
  • Corrective and preventive actions
  • Validation tracking
• Ensure CAPA status tracking with automatic escalation alerts
• Support QE with data analytics during root cause investigations

Data Governance & Integrity

• Establish data validation controls
• Perform periodic data audits
• Ensure secure access controls
• Maintain version control and backup integrity

Qualifications

• Bachelor’s degree in Engineering, Data Analytics, Quality, or related field
• 3–7 years experience in Quality Systems or Data Analytics within manufacturing
• Strong proficiency in:
  • SQL
  • Excel (advanced formulas, pivot tables, macros)
  • Power BI / Tableau (or similar BI tools)
• Experience with QMS software platforms preferred
• Familiarity with ISO 9001:2015 structure
• Understanding of CAPA and 8D processes

Core Competencies

• Database structure thinking
• Process mapping
• Workflow automation
• Audit defensibility
• Multi-site data integration
• Executive reporting clarity

What This Role Is Not

• Not a clerical data entry role
• Not purely document control

Not IT-only — must understand quality systems