PMO Team Member - Tool Validation & QMS Automation

You will be joining the Engineering Operations team in the Digital Unit as a PMO Team Member specializing in Tool Validation & QMS Automation. Your primary focus will be on driving tool validation projects, automating validation processes, QMS documentation automation, and researching productivity-enhancing tools. Your role will play a crucial part in ensuring compliance with regulatory standards such as FDA, ISO 13485, IEC 62304, and IEC 82304-1, while also fostering innovation and operational efficiency within engineering and quality processes. The ideal candidate should have a strong understanding of software validation in regulated environments. Your responsibilities will include: - Managing the lifecycle of tool validation projects, from planning and risk assessment to testing and documentation. - Developing and maintaining validation plans, protocols, and summary reports in compliance with regulatory requirements. - Implementing automated validation frameworks for recurring tasks using modern scripting, CI/CD tools, or generative AI techniques. - Identifying opportunities to automate the creation, review, and management of QMS documents using AI tools, templates, or custom scripts. - Evaluating and deploying document automation tools compatible with QMS platforms in collaboration with Quality, Engineering, and IT teams. - Continuously evaluating emerging tools and technologies to enhance engineering productivity, traceability, testing, and compliance. - Acting as a bridge between Quality, Engineering, and IT to streamline tooling decisions and validations. - Maintaining dashboards and metrics for tool usage, compliance status, automation ROI, and productivity KPIs. - Facilitating project governance and stage-gate reviews for tool-related initiatives. Qualifications required for this role include: - Bachelor's degree in engineering, Computer Science, Quality, or related discipline. - 5+ years of experience in regulated industries such as medical devices, pharma, SaMD, or life sciences. - Experience with digital health software, including regulated SaMD and health IT platforms. - Strong knowledge of software tool validation, including CSV under FDA 21 CFR Part 11, ISO 13485, or GAMP 5. - Experience with QMS systems, documentation requirements, and modern document automation platforms. - Experience with AI/ML or low-code automation tools and familiarity with productivity and lifecycle tools. - Excellent communication, stakeholder management, and technical documentation skills. - Strong understanding of Product/Software Development lifecycle and Agile/DevOps methodologies. Preferred qualifications may include experience with design control frameworks, risk management, DevOps toolchains, infrastructure-as-code, and vendor assessment processes. Success in this role will be measured by metrics such as a reduction in tool validation cycle time, the percentage of QMS documents managed through automated workflows, tool adoption rates, user satisfaction post-deployment, and audit readiness related to tools and documentation.,