Senior SQA Engineer
3B Staffing LLC, Chicago, IL, United States
Skill Matrix :
7+ 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.
Responsibilities:
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+ 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.
Responsibilities:
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.