Position Summary: 

The Quality Labeling Graphic Designer oversees the creation and revision of product labeling, adhering to corporate and branding guidelines, to support existing and new products both domestically and internationally.  The Quality Labeling Graphic Designer ensures compliance to FDA and ISO standards, IVDR and MDR regulations, IVDD and MDD directives and other regulations as they pertain to labeling/labels.

DUTIES/RESPONSIBILITIES:

• Oversee the labeling process for new and existing IVD and MD products.
• Interface with Marketing, Regulatory Affairs, Supply Chain Management, Engineering, Clinical, and Manufacturing in the labeling development and revision process to ensure the requested deliverables are correct and meet specifications.
• Develop and maintain the design and layout of product manuals, IFUs, packaging and labels.
• Incorporate redlined changes made to artwork drafts to create final drafts and source files.
• Clarify open questions and request missing information on redlined artwork.
• Assist labeling creators/reviewers based on a strong understanding of regulatory standards and guidelines for IVD and MD labeling/labels.
• Proofread and act as departmental quality control for product descriptions and labeling content.
• Create and revise BarTender barcode label PDF artwork and source files.
• Obtain the required labeling requirement approvals.
• Provide documentation for labeling change orders: PDF artwork redlines, PDF artwork final drafts, source files, summary of changes, and certificates of translation.
• Manage translation supplier projects, priorities, budget, and delivery timelines.
• Coordinate with outside suppliers as needed to facilitate the ordering, receipt, and implementation of new and revised labeling.
• Other duties as assigned, according to the changing needs of the business.

TECHNICAL QUALIFICATIONS:

• Strong hands-on experience and ability to develop and evaluate product manuals, instructions for use and other labeling/labels to ensure that the information is complete and correct.
• Proficiency with Adobe Creative Suite - Photoshop, Illustrator and InDesign.
• Experience with BarTender or other barcode label programs is preferred.
• Strong understanding of IVD and MD labeling/label standards, regulations, directives and guidances.
• Basic understanding of change control requirements
• Computer literacy required; good working knowledge of Microsoft Office programs
• Strong planning, organizational and time management skills are required
• Ability to prioritize urgent matters

COMPETENCIES:

• Attention to Detail:  Ability to pay close attention to detail is required​
• Accuracy:  Work is accurate and completeness of records​
• Outstanding Performance Standards:  Demonstrated ability to meet department goals​
• Communication:  Good written and verbal communication skills​
• Discretion:  Acts honest, loyal, and trustworthy​
• Multi-Tasking:  Ability to juggle priorities, and support changing business needs​
• Collaboration:  Ability to actively develop a network to bring best solutions to the team or customer​
• Independence: Self-motivated - works under minimal supervision​
• Professionalism:  Must demonstrate professionalism during all interactions within company, customer and third parties​
• Takes Initiative:  Serve as a role model for “Quality First” by continuously improving on what matters most to customers​
• Problem Solving:  Promptly and effectively handles issues and problems