Design, develop, and update global labeling documents to include product labels, instructions for use (IFUs), patient implant cards, specifications, and technical documentation. Job duties :
- Develop strategies for continuous improvement of the Labeling program and procedures.
- Conduct investigations and troubleshooting to address labeling non-conformances and document appropriately per the quality system.
- Provide advice or consultancy to other teams with respect to labeling implementation processes.
- Design, develop, and implement changes to new and existing product labels and instructions for use (IFUs) using labeling and design software.
- Collaborate with labeling change request initiators to understand requirements, design solutions, timelines, and deliverables.
Develop standardized and optimized label templates and identify issues associated with design.
- Ensure labeling compliance with quality management system (QMS), regulatory requirements and guidelines, standard operating procedures, and work instructions.
- Effectively collaborate with cross-functional groups and stakeholders for successful implementation of labeling designs and changes.
- Coordinate with suppliers and vendors for outsourced printed products and translated materials.
- Conduct investigations, root cause analyses, and the development of corrective actions to address labeling non-conformances.
Lead activities to implement corrective actions.
- Complete labeling initiatives by collaborating with individuals from functional groups and providing solutions to meet objectives.
- Assign tasks and provide guidance, mentoring direction to the labeling group and contractors regarding labeling workflow, project status, and priorities.
- Communicate anticipated assignment completion dates to affected coworkers. Meet timeline commitments with minimal supervision.
- Perform other responsibilities as assigned.
10 days ago