Validation Engineer
Listed on 2026-10-01
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Quality Assurance - QA/QC
Regulatory Compliance Specialist
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
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