
Description
Document/Change Management Specialist ( NO C2C or Third Party)
- Location: Mahwah, NJ (07430)
- Duration: 12 Months - Until 8/2026
- Type: W2 contract (NO C2C OR THIRD PARTY)
- Pay: Negotiable depending on DIRECT-RELATED experience up to $45 - $55 an hour
- Work Authorization: Must be currently in the United States with active employment authorization documents.
Primarily responsible for facilitating document related changes in accordance with change management procedures and relevant regulatory requirements for medical devices. This role will be a key player in supporting an implementation GO LIVE project.
Key areas of responsibility
- Facilitate the change management process for document related changes.
- Perform administrative activities related to learning management system.
- Ensure QMS documentation reflects actual business activities while remaining compliant with applicable internal and external regulatory requirements including but not limited to Site, Division, Corporate, FDA, ISO, MDD, MDR and individual country requirements.
- Drive Good Documentation Practices.
- Identify and implement improvement opportunities to increase the efficiency and effectiveness of the QMS and associated documentation.
Required Education, Work Experience & Related Competencies
- BS in a science, engineering, business or related discipline.
- Demonstrated Project Lead and Project Management experience
- Minimum of 3 years' experience in a regulated industry using electronic document/change management systems preferred.
- Basic knowledge and understanding of US and International Medical Device Regulations.
- Ability to plan, organize, and implement multiple concurrent tasks.
- Strong interpersonal skills, written, oral communication and negotiations skills.
- Must demonstrate the ability to effectively communicate up/down and across different levels of the organization.
- Analytical and problem-solving capabilities with the ability to draw insights from data quickly and to define executable actions.
- Basic understanding of compliance risk situations.
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 the United States with active employment authorization documents.
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 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.
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