PMO Lead Tool Validation & QMS Automation Olympus Medical Systems India Pvt Ltd

5.0 - 9.0 years

0 Lacs

hyderabad, telangana

On-site

As a PMO Lead specializing in Tool Validation & QMS Automation, you will be responsible for driving tool validation projects, automating validation processes, QMS documentation automation, and exploring productivity-enhancing tools in the Engineering Operations of the Digital Unit. Your role is pivotal in ensuring compliance with regulatory standards such as FDA, ISO 13485, IEC 62304, and IEC 82304-1 while promoting innovation and operational efficiency within engineering and quality processes. Your key responsibilities will include owning and managing the lifecycle of tool validation projects, developing and maintaining validation plans, protocols, and summary reports, implementing automated validation frameworks, and ensuring tools are in a validated state. You will also be tasked with identifying opportunities to automate the creation, review, and management of QMS documents, leading the evaluation and deployment of document automation tools, and collaborating with various departments to align automation efforts with document control policies. Additionally, you will be responsible for researching and evaluating emerging tools and technologies that enhance engineering productivity, conducting feasibility assessments, and leading vendor engagements for tool-related initiatives. Moreover, you will act as a bridge between Quality, Engineering, and IT to streamline tooling decisions and validations, maintain dashboards and metrics for tool usage and compliance, and facilitate project governance for tool-related initiatives. The successful candidate for this role should hold a Bachelor's degree in engineering, Computer Science, Quality, or a related discipline, possess 5+ years of experience in regulated industries, have a solid understanding of software tool validation, QMS systems, and modern document automation platforms, and be familiar with AI/ML or low-code automation tools. Additionally, experience with digital health software, design control frameworks, risk management, and DevOps toolchains is highly preferred. Your success in this role will be measured by achieving a 20% reduction in tool validation cycle time via automation, ensuring that 10% of QMS documents are generated or managed through automated workflows, tracking tool adoption rate and user satisfaction post-deployment, and maintaining audit readiness and compliance findings related to tools and documentation. If you possess excellent communication, stakeholder management, and technical documentation skills, along with a strong understanding of Product/Software Development lifecycle and Agile/DevOps methodologies, we encourage you to apply for this challenging and rewarding position.,

Posted 3 days ago

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PMO Team Member - Tool Validation & QMS Automation Olympus Medical Systems India Pvt Ltd

5.0 - 9.0 years

0 Lacs

hyderabad, telangana

On-site

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.,

Posted 4 days ago

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