Overview
On Site
Up to $50
Accepts corp to corp applications
Contract - W2
Contract - 12 Month(s)
Able to Provide Sponsorship
Skills
Lead and CoordinateLabeling Design Change projectsfor US and Global Medical device products.
DHF
Medical deviceLabeling and packaging re-designand test methods to improvelabel readability
Job Details
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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.
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