Quality Systems Specialist; medical device

Position: Staff Quality Systems Specialist (medical device)
** Staff Quality Systems Specialist**   **-*
* ** _(Medical Device Industry)_*
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** Location** : (ONSITE) - Cary, IL (60013)

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** Duration** : 18+ month contract

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** Type:
** W2 contract (
** _C2C OR THIRD PARTY arrangements will NOT be considered for this role)_*
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** Pay:
** Negotiable depending on direct-related experience up to $48 - $52 an hour

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** 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.

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* Job Summary:

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* + 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

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Job Duties:

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* ** 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

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* Required:

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* + 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 Share Point

** 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

***** (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…