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Job Title: PMO Team Member– Tool Validation & QMS Automation Job Summary: Engineering Operations in Digital Unit are seeking a highly motivated and detail-oriented PMO Lead to drive tool validation, automation of validation processes, QMS documentation automation , and research of productivity-enhancing tools. This role is critical in ensuring compliance with regulatory standards (e.g., FDA, ISO 13485, IEC 62304, IEC 82304-1) while fostering innovation and operational efficiency across engineering and quality processes. The ideal candidate will bridge quality and operations with a strong understanding of software validation in regulated environments. Key Responsibilities: Tool Validation and Automation Own and manage the lifecycle of tool validation projects including planning, risk assessment, requirements, testing, and documentation. Develop and maintain validation plans , protocols (IQ/OQ/PQ) , and summary reports in compliance with applicable regulatory requirements. Implement automated validation frameworks for recurring validation tasks using modern scripting, CI/CD tools, or generative AI techniques. Maintain a validated state of tools including updates, patches, and audit readiness. QMS Document Automation Identify opportunities to automate the creation, review, and management of QMS documents using AI tools, templates, or custom scripts. Lead the evaluation and deployment of document automation tools compatible with QMS platforms (e.g., Jama, ADO, Jira, Polarion). Collaborate with Quality, Engineering, and IT to align automation efforts with document control policies. Tool Research and Productivity Improvement Continuously scan and evaluate emerging tools and technologies that enhance engineering productivity, traceability, testing, and compliance . Conduct feasibility assessments and proof-of-concepts (PoCs) for candidate tools, including ROI, TCO, regulatory fit, and user impact. Create and maintain a tool evaluation matrix and decision logs. Lead vendor engagements, pilot planning, and rollout coordination. Cross-functional PMO Responsibilities Act as the bridge between Quality, Engineering, and IT to streamline tooling decisions and validations. Maintain dashboards and metrics for tool usage, compliance status, automation ROI, and productivity KPIs. Facilitate project governance and stage-gate reviews for tool-related initiatives. Required Qualifications: Bachelor’s degree in engineering, Computer Science, Quality, or related discipline. 5+ years of experience in regulated industries (e.g., medical devices, pharma, SaMD, life sciences). Experience with digital health software, including regulated SaMD (Software as a Medical Device) and health IT platforms. Solid experience with software tool validation , including CSV (Computer Software Validation) under FDA 21 CFR Part 11, ISO 13485, or GAMP 5. Strong knowledge of QMS systems , documentation requirements, and modern document automation platforms. Experience with AI/ML or low-code automation tools (e.g., ChatGPT, Python scripting, Power Automate, Workato). Familiarity with productivity and lifecycle tools (e.g., Azure DevOps, Jama, Jira, GitHub, TestRail). Excellent communication, stakeholder management, and technical documentation skills. Strong experience and understanding of Product/Software Development lifecycle and Agile/DevOps methodologies. Preferred Qualifications: Experience with design control frameworks (IEC 62304, IEC 82304-1). Working knowledge of risk management (ISO 14971). Experience in DevOps toolchains and infrastructure-as-code (IaC) . Familiarity with RFP and vendor assessment processes. Success Metrics: 20% Reduction in tool validation cycle time via automation in the first year. 10% of QMS documents are generated or managed through automated workflows. Tool adoption rate and user satisfaction post-deployment. Audit readiness and compliance findings related to tools and documentation. Visible tool tracking for validation