IT Business Systems Analyst

Job Title: IT Business Systems Analyst

Location: Mundelein, IL ( ONSITE )

Duration : 6+ Months

Primary Skills : Business Analyst, GxP, FDA, Quality

This is Hybrid role 3 days onsite in Mundelein, IL

Role Summary

We are looking for a Business Analyst to support quality and compliance transformation for our Life Sciences and Medical Device clients. You will work between business stakeholders and delivery teams to capture requirements, map quality processes, and shape solutions on FDA-regulated quality systems.

This is a delivery-focused role on an industry-specific vertical built around Business-led, AI-enabled Quality and Compliance Transformation. You will turn quality and regulatory obligations into requirements the delivery team can build and validate against.

This is a hands-on position with room to grow as the vertical expands to other medical device and pharmaceutical clients.

Key Responsibilities

Requirements and Process Analysis

• Elicit and document business and functional requirements from Quality, Regulatory, and Operations stakeholders
• Map current-state and target-state quality processes, including complaint handling, CAPA, nonconformance, change control, design control, audit, and training
• Write user stories, functional specifications, and acceptance criteria
• Maintain requirements traceability from regulation to configuration to test

Solution and Delivery Support

• Support configuration and design decisions on eQMS, PLM design control, LIMS, MES, and electronic device history record platforms
• Support Computer Software Assurance and validation activities, including test scripts and traceability
• Facilitate workshops, backlog refinement, and user acceptance testing with business and technical teams
• Raise and track defects, risks, and decisions through the delivery cycle

Stakeholder and Domain Support

• Act as the link between client quality teams and the delivery organization
• Translate FDA and ISO obligations into system requirements the delivery team can build against
• Contribute to solution assets, process templates, and reusable requirement catalogs for the Quality Vertical

Required Qualifications and Experience

• 8 or more years as a Business Analyst in Life Sciences or Medical Device, or in a quality and regulatory function
• Strong domain knowledge of quality management systems and the regulations that shape them, including FDA 21 CFR Part 820 and the Quality Management System Regulation, ISO 13485, 21 CFR Parts 210 and 211, 21 CFR Part 11, and EU MDR with EUDAMED
• Working knowledge of eQMS, PLM design control, LIMS, MES, and electronic device history record platforms
• Experience with requirements management, process mapping, and user story writing
• Experience supporting validation under Computer Software Assurance or GAMP 5
• Excellent written documentation and stakeholder communication
• FDA-related experience, such as remediation of warning letters or consent decrees, is preferred
• Understanding of AI applications in quality and compliance is a significant advantage

Preferred Skills

• Prior experience with medical device or pharmaceutical manufacturers
• Exposure to quality and regulatory platforms such as TrackWise, ETQ, MasterControl, Veeva Vault Quality, PTC Windchill, STARLIMS, or Rimsys
• Familiarity with Agile delivery and backlog tools such as Jira or Azure DevOps
• Familiarity with Computer Software Assurance and GAMP 5 validation
• A business analysis certification such as CBAP or an IIBA credential is an advantage