Business Process Improvement Analyst

Key Responsibilities

Process Improvement

·         Plan, perform, and implement process improvement initiatives, including Lean and Six Sigma activities.

·         Diagram and evaluate existing processes to identify improvement opportunities.

·         Organize, lead, and facilitate cross-functional project teams.

·         Develop metrics to measure process performance and identify future improvement opportunities.

·         Collect and analyze data to identify root causes of problems.

·         Measure performance against established process requirements.

·         Align improvement initiatives with identified performance gaps.

·         Provide consultation on process re-engineering techniques to improve performance and product quality.

·         Survey and analyze best practices for processes and improvement techniques.

·         Perform cost-benefit analysis for improvement initiatives.

·         Communicate project and team progress.

·         Deliver presentations and training related to measurement, analysis, improvement, and control when required.

Configuration Management & Product Release

·         Prepare and route Change Notifications (CNs) with Product Release and Configuration Assurance teams.

·         Fulfill internal requests for electronic labeling documentation.

·         Review components before CN release to ensure requirements and specifications are met.

·         Create and maintain finished goods and models in a Product Lifecycle Management (PLM) system.

·         Analyze and verify requirements for Unique Device Identification (UDI) registration.

·         Support Device Master Record (DMR) indexing.

·         Contribute to product release metrics and process measurements.

Quality Systems

·         Coordinate product design documentation with Product Release and Quality Systems teams.

·         Perform change-control audits of labeling and packaging components.

·         Perform proofs of labeling components and print-vendor labeling.

·         Follow applicable quality policies, procedures, and quality-system requirements.

·         Ensure documentation and activities meet quality-system compliance requirements.

eManuals Release

·         Perform the eManuals Release Administrator (ERA) role, including staging and releasing manuals to the eManuals website.

·         Coordinate qualification and release activities for eManuals supporting product launches.

·         Participate in user acceptance testing (UAT) as required.

·         Follow established editorial guidelines for eManual records.

·         Participate in requirements definition and testing for new eManual website features.

·         Work with internal and external partners to troubleshoot content, quality, and schedule issues.

·         Negotiate and coordinate resolution of release-related issues.