Label Document Specialist
52 Discovery Irvine, CA 92618 US
Job Description
The Labeling Documentation Specialist is responsible for creating new entries and maintaining large database of control documents related to all aspects of medical device labeling.
Duties & Responsibilities:
Manage label documentation to accurately convey product information and ensure compliance with regulatory requirements.
Update, and maintain labeling documents ( C/O) as part of engineering packaging drawings.
Perform additional duties or special projects as assigned, contributing to continuous improvement initiatives within the labeling department.
Minimum Qualifications:
- Working knowledge of Adobe Illustrator;
- Intermediate in Excel
- Familiar with Agile and CO workflows
- Experience in a document control / engineering setting
- Experience with documentation approval systems; (Agile)
- Must be highly PC literate
- Good communications skills/ ability to work with multiple departments
- Detail Oriented and can follow instructions
- Familiar with BarTender – it’s a plus, but not required
- Have knowledge about EU MDR requirements – it’s a plus, but not required
- Familiar with AutoCad/SolidWorks – it’s a plus, but not required
High School Diploma or GED Certificate
Certified Training in CAD Drafting AutoCad or Solidworks is a plus.
A.A. in packaging design or related field is a plus
B.S. Degree in packaging design or related field is a plus
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.