Software Validation Specialist - QA & Regulatory (Hybrid)

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

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.