CSA Quality Systems Engineer

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