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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 [email protected].

_*** (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.

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here (https://www.mykelly.com/help-support-working-with-kelly-us/#Benefits) for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly ® Engineering?

Your engineering skills are in demand, but how do you find the right fit? Easy. At Kelly Engineering, our team creates expert talent solutions to solve the world’s most critical challenges. We connect you with leading organizations where you can collaborate on innovative projects, work with cutting-edge technologies and accelerate your growth. Whether you prefer the variety and flexibility of short-term projects or are looking for a long-term opportunity, we’re here to guide you to the next step in your engineering career.

About Kelly

Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.