Quality Systems & Data Analyst

Burlington MedicalNewport News, VA
Onsite

About The Position

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.

Requirements

  • 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
  • Strong proficiency in Excel (advanced formulas, pivot tables, macros)
  • Strong proficiency in Power BI / Tableau (or similar BI tools)
  • Familiarity with ISO 9001:2015 structure
  • Understanding of CAPA and 8D processes
  • Ability to read, write, and comprehend simple instructions in English.
  • Ability to effectively present information in one-on-one and small group situations to other employees of the organization.
  • Ability to apply basic understanding to carry out instructions furnished in written, oral, or diagram form

Nice To Haves

  • Experience with QMS software platforms preferred

Responsibilities

  • 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
  • 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), and Audit findings
  • Create executive-level and operational-level reports
  • 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
  • Develop and maintain electronic workflow systems for 8D investigations, Corrective and preventive actions, and Validation tracking
  • Ensure CAPA status tracking with automatic escalation alerts
  • Support QE with data analytics during root cause investigations
  • Establish data validation controls
  • Perform periodic data audits
  • Ensure secure access controls
  • Maintain version control and backup integrity
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