Demonstrate strong commitment to the Quality Policy and compliance with 21 CFR Part 820, ISO 13485, and BSC Quality System requirements. Build quality into all aspects of work and support compliant solution design. Conduct quality impact assessments and execute Full Track CN approvals in Windchill. Apply effective problem-solving methodologies to resolve quality issues. Bachelor's degree in Engineering, Science, or related field. 5+ years of Quality Engineering or Quality Systems experience in a regulated environment. Ability to perform Full Track CN approvals in Windchill. Strong understanding of ISO 13485 and 21 CFR 820. Experience supporting process or system transformation initiatives. Excellent communication, documentation, and stakeholder management skills. Experience with SAP S/4HANA or large-scale ERP modernization. Experience with systems such as SAP, Salesforce, Coupa, or MDG. Knowledge of Agile methodologies and UAT execution. Strong analytical and technical writing skills. Software validation or digital quality systems experience. Systems thinker with strong analytical skills. Comfortable operating in ambiguity with ability to bring clarity. Strong relationship builder and collaborator. High accountability, professionalism, and attention to detail. Able to work effectively across functions and geographies. Analyze, document, and validate quality-related business requirements. Facilitate workshops to evaluate current-state and future-state workflows. Develop and execute UAT scripts, test plans, and traceability matrices. Ensure change control and documentation governance are upheld. Provide coaching and SME support to Quality Engineers and Technicians. Support CAPA, Lean, and continuous improvement initiatives. Audit & Quality Systems Support Support audit readiness and document non-conformances. Contribute to development of streamlined quality business systems.