Validation Engineer

Quality Assurance Analyst, Software Validation

Chicago, IL area (Hybrid) | Regulatory Affairs / Quality Assurance

About the Role

Our client, a global manufacturer in the medical device and in-vitro diagnostics (IVD) space, is looking for a Quality Assurance Analyst, Software Validation to join their Regulatory Affairs / Quality Assurance organization. This role sits at the intersection of software quality, computer systems validation, and regulatory compliance — supporting both new system implementations and ongoing enhancements across a highly regulated environment.

You'll work cross-functionally with Enterprise Systems, Regulatory Affairs/QA, Technical Services, and business teams to validate systems, guide change management, and continuously improve quality processes across the organization.

What You'll Do

• Guide validation efforts and develop/review key deliverables — Validation Plans, Software Requirement & Design Specifications, Risk Analyses, Test Plans & Protocols, and Validation Summaries/Reports
• Ensure new development and system maintenance comply with validation procedures, software lifecycle management, design control, and change control (including risk management)
• Partner with Regulatory Affairs, QA, Enterprise Systems, and Technical Services to strengthen product development, design, validation, and change control processes
• Support QA teams with software-related releases, customer complaints, CAPA, and field correction/recall activities
• Provide oversight of design and validation activities across core business systems and infrastructure supporting sales, service, and supply chain functions, including CRM and SAP HANA platforms
• Support validation of manufacturing equipment and process changes
• Serve as a validation and software lifecycle resource for global partners/affiliates
• Author, review, and revise SOPs and other controlled documents

What You'll Bring

• Bachelor's degree plus 3–5 years of experience in software systems and software validation processes within a Quality Assurance function (or equivalent experience, including military experience)
• Working knowledge of medical device quality systems, design control, and software development processes, including risk management
• Experience with medical device CAPA evaluation, rework, and resolution
• Familiarity with FDA QSR/QMSR, 21 CFR Part 11, ISO 13485, and ISO 14971
• Understanding of software design and software lifecycle management principles
• Solid grounding in qualification, verification, and validation practices
• Strong technical/procedural writing skills
• Proficiency with standard business systems (CRM, SAP HANA) and Microsoft Office
• Excellent written and verbal communication skills; ability to train and coach others
• Minimal travel required (0–5%)