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Medical Device Labeling Specialist (QMS)
Portage, MI, US
Engineering
Bachelors Degree
Full Time, Temporary
Experienced (Non-Manager)
On-site
Medical Devices and Supplies
First Shift (Day)
Portage, MI, US
Experienced (Non-Manager)
Full Time, Temporary
Medical Devices and Supplies
On-site
Engineering
Bachelors Degree
First Shift (Day)
Job details
Medical Device Labeling Specialist (QMS)
- Location: Portage, Michigan (49002)
- Duration: 6 month assignment (Contract extension potential)
- Type: W2 contract (NO C2C OR THIRD PARTY)
- Pay: Negotiable depending on direct-related experience
- Work Authorization: Must be currently in the United States with active employment authorization documents without current sponsorship.
Summary:
In this role you will 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.
- 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.
Key Responsibilities
- 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
- Ensure barcodes pass verification testing
- Select appropriate label materials for labels applied to packages and products in collaboration with packaging engineers
- Support multiple concurrent labeling projects for new products and label maintenance
- 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
- Provide reviews of regulatory documentation to ensure that medical device labeling references are complete and correct and compliant with FDA and EU requirements
Important information: To be immediately considered, please send an updated version of your resume to Deas172@kellyservices.com.
*** (Kelly does not expense relocation/interview costs)**
- Work Authorization: Must be currently in and able to work in the United States with current employment authorization documents without current sponsorship.
9857390
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