Job Description

Job Description

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

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• Guide validation efforts and develop/review key deliverables — Validation Plans, Software Requirement & Design Specifications, Risk Analyses, Test Plans & Protocols, and Validation Summaries/Reports
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• Ensure new development and system maintenance comply with validation procedures, software lifecycle management, design control, and change control (including risk management)
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• Partner with Regulatory Affairs, QA, Enterprise Systems, and Technical Services to strengthen product development, design, validation, and change control processes
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• Support QA teams with software-related releases, customer complaints, CAPA, and field correction/recall activities
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• 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
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• Support validation of manufacturing equipment and process changes
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• Serve as a validation and software lifecycle resource for global partners/affiliates
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• Author, review, and revise SOPs and other controlled documents
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What You'll Bring

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