Validation Engineer

Forbes Technical Consulting LLC; Illinois; Hybrid; USD 90,000 - 120,000; Full time

Job summary

Forbes Technical Consulting LLC is seeking a Quality Assurance Analyst, Software Validation in the Chicago, IL area. This hybrid role sits within Regulatory Affairs / Quality Assurance, focusing on software validation, lifecycle management, and regulatory compliance for medical device/IVD systems.

You will guide validation efforts, develop deliverables, and collaborate across QA, regulatory, and enterprise systems to improve quality processes. Strong writing and communication skills are required.

Qualifications

• Bachelor’s degree plus 3–5 years of software systems and software validation experience in QA.
• Experience with medical device quality systems, design control, and risk management.
• Familiarity with FDA QSR/QMSR, 21 CFR Part 11, ISO 13485, and ISO 14971.
• Understanding of software lifecycle and validation practices.
• Strong technical and procedural writing skills.
• Proficiency with CRM and SAP HANA; MS Office.
• Excellent written and verbal communication; ability to train others.

Responsibilities

• Lead validation efforts and develop key deliverables (plans, specs, risk analyses, test plans, validations reports).
• Ensure development and maintenance align with validation procedures and lifecycle management.
• Collaborate across Regulatory Affairs, QA, Enterprise Systems to strengthen processes.
• Support QA teams with software releases, CAPA, and field corrections/recalls.
• Oversee design and validation activities across core systems including CRM and SAP HANA.
• Validate manufacturing equipment and process changes.
• Author, review, and revise SOPs and controlled documents.
• Serve as validation resource for global partners.

Skills

Software validation

Quality Assurance

Regulatory compliance

Technical writing

Communication skills

Education

Bachelor’s degree

Tools

CRM system

SAP HANA

Microsoft Office

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

• 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