{"schemaVersion":"jobsearcher.job.v1","id":"e75fbe8a95082a822f994da7","url":"https://jobsearcher.com/jobs/e75fbe8a95082a822f994da7","canonicalUrl":"https://jobsearcher.com/jobs/e75fbe8a95082a822f994da7","title":"CSA Quality Systems Engineer","description":"JOB DESCRIPTION    Our client is We are seeking a CSA Quality Systems and Validation Expert to join their team as part of an ongoing ERP Transformation Program. This is a critical role, responsible for ensuring the quality and compliance of their ERP systems and related processes, in line with industry standards and regulatory requirements. You will be a key contributor in rewriting compliance plans, trace matrices, and test plans, ensuring that the systems are validated for operational effectiveness and compliance.Key Responsibilities:Re-write Compliance Plans: Develop and update compliance documentation to ensure systems meet internal and external regulatory requirements.Trace Matrices Development: Design, implement, and maintain traceability matrices to track requirements, design, testing, and validation activities.Test Plans and Execution: Create and update detailed test plans, including test case development, execution, and validation reporting, ensuring alignment with ERP transformation goals and compliance requirements.Quality Systems Expertise: Leverage deep knowledge of quality systems and validation processes to ensure best practices are followed throughout the ERP transformation project lifecycle.Collaboration and Stakeholder Management: Work closely with cross-functional teams including IT, regulatory, compliance, and project management to align quality and validation activities with overall project objectives.Risk Management: Identify potential risks associated with system implementation and propose mitigation strategies.Documentation and Reporting: Maintain detailed documentation of all validation processes, test results, and compliance efforts to support internal audits and regulatory reviews.Tool Utilization: Leverage tools such as Jira, Jama, and DevOps (or similar tools) to manage requirements, testing, and validation tasks efficiently.Required Skillset   ·        5+ years of experience in quality systems and validation, particularly in a CSA·        Extensive Medical Device Industry Experience·        Hands-On experience with tools like: Jira, Jama, and Dev Ops","company":"Ls Solutions","rawCompany":"ls solutions","city":"Denver","state":"CO","isRemote":false,"isActive":false,"createdAt":"2026-08-14T11:37:17.489Z","occupations":[{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"15-1253.00","title":"Software Quality Assurance Analysts and Testers","slug":"software-quality-assurance-analysts-and-testers"},{"code":"11-3051.01","title":"Quality Control Systems Managers","slug":"quality-control-systems-managers"}],"industries":[{"code":"541512","title":"Computer Systems Design Services","slug":"computer-systems-design-services"},{"code":"541511","title":"Custom Computer Programming Services","slug":"custom-computer-programming-services"},{"code":"513210","title":"Software Publishers","slug":"software-publishers"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"CSA Quality Systems Engineer","description":"JOB DESCRIPTION    Our client is We are seeking a CSA Quality Systems and Validation Expert to join their team as part of an ongoing ERP Transformation Program. This is a critical role, responsible for ensuring the quality and compliance of their ERP systems and related processes, in line with industry standards and regulatory requirements. You will be a key contributor in rewriting compliance plans, trace matrices, and test plans, ensuring that the systems are validated for operational effectiveness and compliance.Key Responsibilities:Re-write Compliance Plans: Develop and update compliance documentation to ensure systems meet internal and external regulatory requirements.Trace Matrices Development: Design, implement, and maintain traceability matrices to track requirements, design, testing, and validation activities.Test Plans and Execution: Create and update detailed test plans, including test case development, execution, and validation reporting, ensuring alignment with ERP transformation goals and compliance requirements.Quality Systems Expertise: Leverage deep knowledge of quality systems and validation processes to ensure best practices are followed throughout the ERP transformation project lifecycle.Collaboration and Stakeholder Management: Work closely with cross-functional teams including IT, regulatory, compliance, and project management to align quality and validation activities with overall project objectives.Risk Management: Identify potential risks associated with system implementation and propose mitigation strategies.Documentation and Reporting: Maintain detailed documentation of all validation processes, test results, and compliance efforts to support internal audits and regulatory reviews.Tool Utilization: Leverage tools such as Jira, Jama, and DevOps (or similar tools) to manage requirements, testing, and validation tasks efficiently.Required Skillset   ·        5+ years of experience in quality systems and validation, particularly in a CSA·        Extensive Medical Device Industry Experience·        Hands-On experience with tools like: Jira, Jama, and Dev Ops","datePosted":"2026-08-14T11:37:17.489Z","dateModified":"2026-08-14T11:37:17.489Z","hiringOrganization":{"@type":"Organization","name":"Ls Solutions","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Denver","addressRegion":"CO","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"e75fbe8a95082a822f994da7"},"url":"https://jobsearcher.com/jobs/e75fbe8a95082a822f994da7"}}