Location: Gainesville,FL, USA
Process Engineer, Packaging
Department: Manufacturing
Employment Type: Full Time
Location: Gainesville, FL
Reporting To: Mgr Pkg & End of Line Engineering
Description
Design, develop, and update global labeling documents to include product labels, instructions for use (IFUs), patient implant cards, Patient Information Leaflet, specifications, and technical documentation.
Key Responsibilities
* Develop strategies for continuous improvement of the Labeling program and procedures.
* Act as subject matter expert for the business with respect to labeling design, requirements, and implementation and labeling software and effectively collaborate on labeling changes.
* Design, develop, and implement changes to new and existing product labels, patient implant cards, Patient Information Leaflet, and instructions for use (IFUs) for use in manufacturing.
* Develop and maintain 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.
* Coordinate with suppliers and vendors for outsourced printed products and translated materials.
* Effectively manage labeling projects from ideation through completion.
* Know and apply the Exactech Quality System and any appropriate Federal and International Standards.
* Perform other responsibilities as assigned.
Skills Knowledge and Expertise
Education:
* Bachelor's degree in related field or equivalent combination of education and experience.
Experience:
* A minimum of three (3) years of experience in a medical device or pharmaceutical FDA regulated environment producing technical documentation and in labeling and digital design software platforms, including labeling database management.
Functional/Technical Knowledge, Skills and Abilities Required:
* High level of attention to detail and sustained focus.
* Demonstrated project management skills and experience.
* Strong computer skills in Adobe Suite, Microsoft Office, project management software and databases.
* Excellent problem-solving, organizational, analytical, and critical thinking skills.
* Ability to work in a cross-functional environment while building positive internal/external working relationships.
* Excellent written and verbal communication skills.
* Demonstrated experience with labeling software or design desired