Senior Quality Systems Specialist

Senior Quality Systems Specialist

• Type: W2 contract (C2C OR THIRD PARTY arrangements will NOT be considered for this role)

• Location: Cary, Illinois (60013) -100% onsite

• Length : 12-month contract - Estimated to end: 10/26/2026 - (Contract extension possibility or internal hire potential)

• Pay Rate - Negotiable depending on DIRECT-related experience up to $50 - $60 an hour

• Work Authorization : Must be physically located in United States and have CURRENT United States employment authorization documents WITHOUT sponsorship transfer requirements.

Job Summary and Requirements:

• Thorough knowledge and understanding of US and International Medical Device Regulations, including MDSAP, with direct experience in US 510(k) and EU Class II devices.

• Strong knowledge of Quality Systems (Measurement, Analysis, and Improvement; Adverse Event and Advisory Reporting; Purchasing; Design and Development; Production and Service Controls, etc.)

• Expert working knowledge of regulatory requirements, standards, and regulations with significant audit experience.

• Strong communication, project management and influencing skills.

• 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.

• Demonstrated ability to make timely and sound decisions through effective approaches for choosing a course of action or developing appropriate solutions.

• Act with a customer service/stakeholder-focused approach.

• Leverages excellent interpersonal keys to achieve desired outcomes.

• Experience in compliance risk situations.

• Experience in technical writing and procedure development.

• Some travel may be required.

Important information: To be immediately considered, please send an updated version of your resume to [email protected].

*(Kelly Services does not expense relocation or interview costs)*

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

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.

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.