We are seeking a Labeling Engineer for an 18 month project with our client in Portage, MI. The position is W2 hourly with Roth Staffing (Ledgent Tech is a division of Roth), with all work taking place for our client.
Pay Rate Range: $66.66/hr. - $93.33/hr.
Description/Comment:
Under minimal supervision, develops and maintains labels for medical devices. Collaborates with product subject matter experts to gather and assess labeling content. Executes label format and compiles content using specialized software. Audience for labels includes hospital and healthcare staff in global markets. Labels must comply with medical device regulations, standards, and business requirements.
Additional Job Details:
Collaborate with product SMEs to assess and determine label requirements and content: Regulatory Affairs, Product Development, Product Safety Engineering, Packaging Engineers, Clinical Sciences, Marketing, Trade Compliance, etc.
* Participate in new product label planning meetings and capture requirements using quality system planning documents.
* Design label formats for functional usability by healthcare staff
* Use specialized labeling software to generate templates and enter label data, text, and graphics into label database for print-on-demand label system
* Use desktop publishing software to design labels produced by external suppliers * Ensure barcodes pass verification testing
* Select appropriate label materials for labels applied to packages and products in collaboration with packaging engineers
* As needed, support label translation strategies that satisfy international labeling needs * Support multiple concurrent labeling projects for new products and label maintenance
* Review labels for completeness and presentation including labels created by others
* Contact external suppliers to resolve label output details.
* Manage labels in PLM/CMS system for controlled label releases and revision management.
* Manage work to meet project milestones.
* Inform project managers of relevant aspects of language translation and impact to label design.
* Communicate impact of language translation for alignment with project timelines and cost
* Collect and track data/metrics associated with projects
* Provide reviews of regulatory documentation to ensure that medical device labeling references are complete and correct and compliant with FDA and EU requirements
All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, and Los Angeles County Fair Chance Ordinance. For unincorporated Los Angeles county , to the extent our customers require a background check for certain positions, the Company faces a significant risk to its business operations and business reputation unless a review of criminal history is conducted for those specific job positions.
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