QMS Specialist - (NO C2C OR THIRD PARTY)

• Location: Mahwah, New Jersey (07430)

• Duration: 12+ month contract until 11/2025 (contract extension potential OR internal hire possibilities)

• 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.

This is an individual contributor role. Primarily responsible for facilitating document and product related changes in accordance with company’s change management procedures and relevant regulatory requirements for medical devices.

Duties Include but not limited to:

• Facilitate the change management process for document and product related changes.

• Perform administrative activities related to learning management system.

• Assist with the migration of QMS related documentation from local document management systems to PLM system (Windchill).

• 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 Manufacturing Practices and Good Documentation Practices.

• Identify and implement improvement opportunities to increase the efficiency and effectiveness of the QMS and associated documentation.

• Develop and deliver training for QMS areas of expertise.

• Engage the IT team in relevant PLM system discussions.

Required:

• BS in a science, engineering, business or related discipline.

• Minimum of 3 years experience in a regulated industry using electronic document/change management systems preferred.

• Thorough knowledge and understanding of US and International Medical Device Regulations.

• Strong knowledge of Quality Systems (CAPA, audits, Management Review, Quality Planning, etc.)

• 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.

• Demonstrated ability to work in cross-functional team environments.

• 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 able to work in the United States with current employment authorization documents.

In addition to working with the world’s most recognized and trusted name in staffing, Kelly employees can expect:

• Competitive pay

• Paid holidays

• Year-end bonus program

• Recognition and incentive programs

• Access to continuing education via the Kelly Learning Center

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 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. 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.