Senior Quality Assurance (QA) Engineer.

Senior Quality Assurance (QA) Engineer.

Type: Contract to Hire (6 months contract then hire)

Location: 100% onsite at Libertyville, IL.

Job Summary:

We are seeking an experienced and detail-oriented Senior Quality Assurance (QA) Engineer to lead our testing and digital validation efforts. In this role, you will be responsible for defining test strategies, building robust automation frameworks using the Tricentis Suite, and ensuring compliance through computerized systems validation (CSV). The ideal candidate possesses deep technical expertise in Tricentis Tosca and qTest, along with a strong working knowledge of Tricentis Vera for managing electronic signatures and automated validation records in a heavily regulated environment. [1, 2]

Key Responsibilities

• Automation & Test Management: Lead the architectural design, development, and maintenance of automated testing frameworks using Tricentis Tosca. Manage test planning, execution, and defect tracking via Tricentis qTest and Atlassian Jira. [1, 2]
• Digital Validation Compliance: Utilize Tricentis Vera to implement digital validation workflows, ensuring all test execution records, electronic signatures, and approvals strictly comply with FDA 21 CFR Part 11 and GxP standards.
• Agile & DevOps Integration: Integrate automated testing frameworks and validation protocols seamlessly into the CI/CD deployment pipelines, bridging the gap between fast-paced Agile development and rigorous compliance verification.
• Documentation & Audit Readiness: Author, review, and execute formal Validation Protocols, Test Plans, Test Scripts, and Summary Reports. Maintain pristine, audit-ready testing artifacts to support internal and external regulatory inspections. [1]
• Collaboration & Leadership: Act as the primary liaison between QA automation engineers, software developers, DevOps personnel, and Regulatory Compliance officers. Provide mentorship, training, and guidance to junior team members on Tricentis toolsets and validation workflows.
• Risk & Defect Management: Conduct risk assessments on software requirements to determine testing scope. Track, analyze, and report on software quality metrics and validation statuses to senior leadership.

Required Qualifications

• Education: Bachelor’s degree in Computer Science, Bioengineering, Information Technology, or a related technical/scientific field.
• Experience: 5+ years of hands-on experience in Software Quality Assurance, with a minimum of 2–3 years operating within a strictly regulated industry (e.g., life sciences, healthcare, medical devices, or finance).
• Tricentis Suite Expertise: Mastery of Tricentis Tosca (including API testing, TBox, and Model-Based Test Automation) and Tricentis qTest for comprehensive test management.
• Vera Knowledge: Proven experience or deep conceptual knowledge of Tricentis Vera (formerly Vera by Synergis Technologies) for automated digital validation, pre/post-execution approvals, and electronic signature management.
• Regulatory Compliance: Robust understanding of computerized systems validation (CSV) methodologies, GAMP 5 guidelines, and FDA 21 CFR Part 11 regulations.
• Tools & Ecosystem: Strong familiarity with Atlassian Jira, Confluence, and common CI/CD tools (e.g., Jenkins, GitLab, Azure DevOps).
• Skills: Strong analytical, troubleshooting, and communication skills, with a proven ability to interpret complex regulatory guidelines into actionable automated test scripts. [1, 2, 3, 4, 5]

Preferred Qualifications:

• Certified Tricentis Tosca Automation Specialist (AS1/AS2) or Test Design Specialist (TDS1/TDS2).
• Direct experience participating in automated systems validation audits or regulatory inspections.
• Experience with Tricentis NeoLoad for performance testing or Tricentis Data Integrity