Sr. Labeling Documentation Specialist
52 Discovery Irvine, CA 92618 US
Job Description
Job Summary:
The Senior Labeling Specialist is responsible for creating new entries and maintaining large database of control documents related to all aspects of medical device packaging. This position will have the responsibility for label creation with a primary focus on variable information labels printed on the production line. Additionally, this person will manage projects which may involve collaborating with multiple contributors throughout the company on large scale projects.
Reporting Relationships:
This job reports to: Manager, Labeling. Reporting directly (or indirectly) to this position are the following job titles: Not Applicable.
Duties & Responsibilities:
· Develop and manage label documentation to accurately convey product information and ensure compliance with regulatory requirements.
· Maintain a comprehensive database of Global Trade Item Number (GTIN) for all products.
· Review translations for labels intended for markets outside the United States, ensuring content accuracy and regulatory compliance.
· Manage country-specific labels and coordinate language translations for packaging labels to meet regional regulatory standards and quarterly revenue targets.
· Incorporate Visual Basic Scripts and database connections within label software to facilitate the generation of variable data fields for labels.
· Create, update, and maintain labeling documents as part of engineering packaging drawings.
· Manage label stock material specifications, collaborating with manufacturing teams to ensure materials meet project requirements.
· Troubleshoot printer and barcode scanner issues with manufacturing teams to maintain operational efficiency.
· Collaborate with cross-functional teams and external vendors to coordinate project timelines and deliverables, ensuring projects are executed on schedule and align with company objectives.
· Support cost reduction projects.
· Perform additional duties or special projects as assigned, contributing to continuous improvement initiatives within the labeling department and organization-wide.
Minimum & Preferred Qualifications and Experience:
Minimum Qualifications:
· Experienced user on the latest versions of AutoCAD or Solidworks;
· Experienced user on Adobe Illustrator;
· Working knowledge of barcode/label creation software (eg. BarTender);
· Familiar with Agile or equivalent automated product lifecycle management system;
· Experience in packaging of instruments, electronics or medical products; (or another regulated products industry)
· Experience with database and documentation systems;
· 3+ yrs experience overseeing packaging and labeling projects from design to production;
· Portfolio of various packaging labeling projects;
Preferred Qualifications:
· 5+ years developing and managing label documentation for a medical company;
· Proven expertise in Adobe Illustrator, and a working knowledge of Photoshop;
· Expert in latest versions of AutoCAD or Solidworks with an emphasis on drawing creation;
· Advanced PC experience including Apple/Mac experience a plus;
· Experience with Bartender (barcode label software)
· Experience managing custom label development with outside vendors;
Education:
High School Diploma or GED Certificate and Certified Training in CAD Drafting AutoCad and/or Solidworks is required. A.A. in packaging design or related field is preferred. B.S. Degree in packaging/labeling design or related field is highly desirable.
Meet Your Recruiter
Nina McCann
On-Site Manager
A native to Orange County, Nina’s staffing career began in 2006 placing quality engineering candidates with distinguished companies as a successful recruiter and client manager. Nina specializes in recruiting for mechanical and electrical engineers in all industries from aerospace, medical device and manufacturing. She understands the engineering programs and importance of matching specific technical skills for position success. Her strong connections within the industry have been vital in her success. Nina’s excitement in placing engineers is due to the direct impact the products have on people’s lives: Everything we touch has been engineered in one form or another. She currently works as an on-site manager at a prominent medical device company.
Outside of work, Nina has been a dedicated volunteer to local nonprofit organizations for the past 15 years. She also enjoys being outdoors, hiking and spending time with her three children.