Senior SQA Engineer

• Lead and execute software validation activities across the SDLC, including development, review, and approval of deliverables such as validation plans, FMEA/risk assessments, requirements, IQ/OQ/PQ, traceability matrices, and system releases.
• Perform independent SQA review and approval of SDLC documentation to ensure compliance with GxP regulations, internal procedures, and industry standards.
• Ensure all IT validation packages are inspection-ready and maintain a continuous state of audit compliance.
• Collaborate cross-functionally with IT, development teams, and business SMEs to support validation efforts and ensure alignment with business and regulatory requirements.
• Review and provide quality oversight for CAPAs, change controls, and software defects, ensuring appropriate validation impact assessment and resolution.
• Contribute to validation strategy development and continuous improvement initiatives for regulated IT systems and processes.
• Support implementation and validation of automated testing frameworks and tools to enhance efficiency and quality of software validation activities.

• 7-12 years of SDLC experience in the Pharmaceutical and Medical Device industries.
• 7+ years of Software Quality Assurance and Computer System Validation experience.
• Hands on experience in validation plans, FMEA, requirements, IQ/OQ/PQ, traceability matrices, system releases.
• Experience reviewing and approving validation documentation, CAPAs, change controls, and defect management processes.
• Strong knowledge of GxP regulations, validation principles, risk management methodologies.
• Experience with automated testing tools and platforms (JIRA, Confluence, HP ALM, Tosca, QTest, M-Files or similar systems).
• Experience with AWS, Databricks, GitHub, or CI/CD tools is preferred.

Required

• 7+ years of experience in Software Quality Assurance and Computer System Validation within regulated environments.
• Hands-on experience authoring and executing SDLC validation deliverables (e.g., validation plans, FMEA, requirements, IQ/OQ/PQ, traceability matrices, system releases).
• Strong knowledge of GxP regulations, validation principles, risk management methodologies, and industry best practices.
• Demonstrated experience reviewing and approving validation documentation, CAPAs, change controls, and defect management processes.
• Familiarity with both Waterfall and Agile software development methodologies.
• Experience with automated testing tools and platforms; proficiency with tools such as JIRA, Confluence, HP ALM, Tosca, QTest, M-Files, or similar systems (experience with AWS, Databricks, GitHub, or CI/CD tools is a plus).
• Strong communication and interpersonal skills with the ability to effectively influence stakeholders, provide regulatory guidance, and operate independently in a cross-functional environment.