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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