Labeling Design SME

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• Lead and Coordinate Labeling Design Change projects for US and Global Medical device products.

• Ensures all Design change activities are planned, approved, and executed.

• Coordinate various team member activities to ensure project plan targets are defined and met.

• Prepare and executes a Design Change Notice to describe the proposed change, the project plan for accomplishing the design changes, and Design transfers.

• Prepare, execute, and organize a formal Design review meeting.

• Prepare and execute Verification and Validation activities (IQ/OQ/PQ).

• Prepare and present, in conjunction with appropriate team members, project status reports, revisions to project plan and issues that may affect project targets or intended product performance or characteristics.
• Execute Medical device Labeling and packaging re-design and test methods to improve label readability, barcode placement, and manufacturing efficiency
• Maintained Good Documentation Practices (GDP) and Change Control documentation throughout the development lifecycle

• Leads collaborative team meetings with cross-functional subject matter experts (SME) to arrive at a consensus for Design changes.

• Prepare and maintains the Design History File (DHF) for the project.
• Participate in investigations related to labeling errors or packaging defects
• Support risk management and change management related to product labeling updates and packaging documentation.

• Manage multiple projects using Project management tools and methods including kick-off meetings, project plan development, timeline management, risks and issue logs, mitigations, status updates, and metrics.

• Work closely with Labeling & Packaging Team, Regulatory & Engineering Team, Purchasing and Vendor representatives to ensure Engineering Change Orders & Requests are fulfilled with best practices to meet FDA Device Labeling (21 CFR Part 801) requirements.