IT Business Systems Analyst

Location: Mundelein, IL
Work Model: Hybrid 3 Days Onsite
Experience: 4+ Years

Job Description

We are looking for an experienced IT Business Systems Analyst with strong experience in Quality Systems and regulated medical/life sciences environments. The ideal candidate will have expertise in GxP, FDA regulations, Design History Files (DHF), Risk Management, EQMS, and PLM systems.

Primary Skills

• Business Analysis / System Analysis
• GxP / FDA / ISO Compliance
• Design History File (DHF) & Design Controls
• Risk Management
• Quality Management Systems / EQMS
• ETQ & PTC PLM
• SAP / ETQ / PTC Integration
• Requirements Gathering & Traceability
• SQL / Power BI / Tableau
• CSV / Validation

Responsibilities

• Collaborate with business, IT, Quality, Compliance, and Data teams to identify business problems and recommend effective solutions.
• Gather, analyze, document, and manage business and system requirements.
• Support Quality Management, Design Controls, Risk Management, and Post-Market Surveillance processes.
• Work with EQMS, PLM, SAP, ETQ, and PTC applications and related integrations.
• Develop process documentation with complete requirements-to-design-to-testing traceability.
• Analyze Quality data using SQL, Power BI, Tableau, or similar tools.
• Identify trends, compliance risks, and opportunities for process improvement.
• Support Agile/Scrum delivery and validation/CSV activities.
• Ensure solutions meet FDA, ISO, GxP, data integrity, and audit-readiness requirements.

Required Qualifications

• Bachelor's degree in Business, IT, Computer Science, or related field.
• 4+ years of Business/System Analysis experience.
• Experience working in Quality or regulated environments.
• Strong knowledge of GxP, FDA, ISO, and Quality processes.
• Experience with DHF, Design Controls, and Risk Management.
• Experience with requirements gathering, system configuration, and integration.
• Strong analytical, problem-solving, stakeholder management, and communication skills.

Preferred

• Experience with ETQ EQMS and PTC PLM.
• Experience with SAP/ETQ/PTC integrations.
• Power Platform: Power Apps, Power Automate, Dataverse.
• WSO2, Talend, APIs, ETL, or event-driven integrations.
• Computer System Validation (CSV).
• Data integrity, audit trails, archiving, and retention.
• Advanced analytics, machine learning, or predictive Quality analytics.