Staff Quality Systems Specialist -(Medical Device Industry)
Location : (ONSITE) - Cary, IL (60013)
Duration : 18+ month contract
Type: W2 contract ( C2C OR THIRD PARTY arrangements will NOT be considered for this role)
Pay: Negotiable depending on direct-related experience up to $48 - $52 an hour
Work Authorization: Must be currently in the United States with active employment authorization documents without current sponsorship transfer requirements. Sponsorship is unavailable for this role.
Job Summary:
We are seeking a highly motivated Staff Quality Systems Specialist (Contractor) to support QMS integration activities by leading and owning the Change Control process within a regulated medical device environment.
In this role, you will ensure that all changes are appropriately documented, assessed for impact, and effectively implemented in alignment with quality and regulatory requirements. You will also mentor cross-functional stakeholders on proper change execution and support the integration of quality system processes across the organization.
This position is ideal for a detail-oriented professional with strong technical writing skills and a deep understanding of how quality system processes interact (e.g., change control, document control, training, and records management).
MUST HAVE:
Change Control & Quality Systems Management
Cross?Functional Collaboration & Stakeholder Management
Process Improvement & Compliance Expertise
Job Duties:
This role requires close collaboration with teams in Germany and flexibility to align with CET/CEST working hours.
Own and manage the Change Control process to ensure compliance, consistency, and effectiveness
Review and approve change records for completeness, accuracy, and appropriate impact assessments
Ensure changes are implemented appropriately, including verification of downstream activities (e.g., documentation updates, training completion, record retention)
Drive process improvements and standardization to support integration efforts
Evaluate process gaps and define compliant, scalable solutions
Collaborate with cross-functional teams to align change activities with integration timelines and business needs
Mentor and guide change owners and stakeholders on proper change control processes
Provide coaching on impact assessment, documentation expectations, and process requirements
Promote consistent and high-quality execution of change activities across the organization
Develop and revise quality system documentation, including procedures, work instructions, and change records
Ensure documentation is clear, accurate, and compliant with internal and regulatory requirements
Partner with Quality, Regulatory, R&D, and Operations teams to ensure alignment on changes and integration efforts
Act as a quality representative in project discussions and integration activities
Communicate progress, risks, and recommendations to key stakeholders
Required:
Bachelor's degree in engineering, science, or a related field
5+ years of experience in quality systems, regulatory, or compliance roles within a regulated industry (medical device preferred)
Proven experience with Change Control processes and quality system integration or harmonization
Experience supporting integration of products, systems, or acquired businesses is strongly preferred
Strong knowledge of Quality Management Systems (QMS) and applicable regulatory requirements (e.g., FDA, ISO 13485, EU MDR)
Deep understanding of interactions between Change Control, Document Control, Training, and Records processes
Excellent technical writing and documentation skills
Strong organizational, problem-solving, and project coordination abilities
Ability to influence, mentor, and drive consistent process execution across cross-functional teams
Ability to manage multiple priorities in a fast-paced, integration-focused environment
Strong attention to detail and commitment to quality and compliance
Collaborative mindset with a proactive, solution-oriented approach
Proficiency in Microsoft Office applications, including Word, Excel, PowerPoint, Teams, and SharePoint
Preferred:
Experience supporting QMS integration in a global environment
German language proficiency (written and verbal)
Work Authorization: Must be currently in the United States with active employment authorization documents without current sponsorship transfer requirements. Sponsorship is unavailable for this role.
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)
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 may use AI-powered tools during the recruitment and hiring process. For full details, including how Kelly uses AI, your rights, and how to request a reasonable accommodation, visit the Recruitment Artificial Intelligence Notice (https://www.kellyservices.com/hubfs/myKelly/Resources/Employment_Policies/Recruitment-Artificial-Intelligence-Notice.pdf?hsLang=en) .
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.
