Senior Software Quality Assurance; SQA) SME
Job in
Lake Forest, Lake County, Illinois, 60045, USA
Listed on 2026-08-27
Listing for:
QvalFocus Inc.
Full Time
position Listed on 2026-08-27
Job specializations:
-
Quality Assurance - QA/QC
-
IT/Tech
Job Description & How to Apply Below
Our client is seeking a Senior SQA SME with 10+ years of experience in Software Quality Assurance, Software Validation, and regulated IT environments. The ideal candidate will have strong experience reviewing and approving SDLC/validation deliverables and ensuring compliance with GxP requirements.
Key Responsibilities- Review and approve SDLC and software validation deliverables, including MVP, FMEA/Risk Assessment, Requirements, IQ/OQ/PQ, Traceability Matrix, and System Release/Certification.
- Review CAPAs, Change Controls, Defects, and deviations related to software validation.
- Ensure validation packages are compliant, complete, and inspection-ready.
- Provide SQA and regulatory guidance to IT, development, QA, and business teams.
- Support validation strategy, continuous improvement, and regulated IT application implementation.
- Work effectively across Agile and Waterfall environments.
- 10+ years of SQA/Software Validation experience.
- Strong knowledge of GxP, CSV/CSA, SDLC, and validation principles.
- Hands-on experience with software validation documentation and SQA review/approval.
- Experience with automated testing and risk management.
- Strong communication and stakeholder management skills.
- Experience with JIRA, Confluence, HP ALM, Tosca, qTest, M-Files, or Veeva.
- Knowledge of AWS, Databricks, Git Hub, Data Lakes, or CI/CD tools is a plus.
Position Requirements
10+ Years
work experience
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