Quality Assurance Analyst, Software ValidationAll the relevant skills, qualifications and experience that a successful applicant will need are listed in the following description. Chicago, IL area (Hybrid) | Regulatory Affairs / Quality AssuranceAbout the RoleOur 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 DoGuide validation efforts and develop/review key deliverables — Validation Plans, Software Requirement & Design Specifications, Risk Analyses, Test Plans & Protocols, and Validation Summaries/ReportsEnsure 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 processesSupport QA teams with software-related releases, customer complaints, CAPA, and field correction/recall activitiesProvide oversight of design and validation activities across core business systems and infrastructure supporting sales, service, and supply chain functions, including CRM and SAP HANA platformsSupport validation of manufacturing equipment and process changesServe as a validation and software lifecycle resource for global partners/affiliatesAuthor, review, and revise SOPs and other controlled documentsWhat You'll BringBachelor'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) xhyhwjd Working knowledge of medical device quality systems, design control, and software development processes, including risk managementExperience with medical device CAPA evaluation, rework, and resolutionFamiliarity with FDA QSR/QMSR, 21 CFR Part 11, ISO 13485, and ISO 14971Understanding of software design and software lifecycle management principlesSolid grounding in qualification, verification, and validation practicesStrong technical/procedural writing skillsProficiency with standard business systems (CRM, SAP HANA) and Microsoft OfficeExcellent written and verbal communication skills; ability to train and coach othersMinimal travel required (0–5%)
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