Quality Management Systems Specialist

Job Title: Quality Management Systems Specialist
Location: Cary, Illinois
Type: Contract
Compensation: $50-55/hr
Work Model: Hybrid – onsite and remote

Overview
Join a global medical technology organization undergoing an exciting quality systems integration initiative. This hybrid contract opportunity offers the chance to lead critical Change Control activities, collaborate with international stakeholders, and drive process improvements within a highly regulated environment. Ideal for an experienced QMS professional who thrives on cross-functional collaboration, compliance excellence, and making a measurable impact on organizational quality and regulatory success.

Responsibilities

• Support QMS integration activities by leading and owning the Change Control process within a regulated medical device environment
• Ensure all changes are appropriately documented, assessed for impact, and effectively implemented in compliance with quality and regulatory requirements
• Mentor cross-functional stakeholders on proper change execution and support the integration of quality system processes across the organization
• Own and manage the Change Control process to ensure compliance, consistency, and effectiveness
• Review and approve change records for completeness, accuracy, and impact assessments
• Ensure changes are implemented correctly, including verification of downstream activities such as documentation updates, training, and record retention
• Drive process improvements and standardization to support integration efforts
• Evaluate process gaps and define scalable, compliant solutions
• Collaborate with teams in Germany to align change activities with timelines and business needs, demonstrating flexibility with CET/CEST hours
• Develop and revise quality system documentation including procedures, work instructions, and change records
• Partner with Quality, Regulatory, R&D, and Operations teams to ensure alignment on changes and integrations
• Act as a quality representative during project discussions and integration activities
• Communicate progress, risks, and recommendations to stakeholders

Requirements

• Bachelor’s degree in engineering, science, or a related field
• 5+ years of experience in a regulated environment, preferably in medical devices
• Proven expertise in Change Control processes and quality system integration or harmonization
• Strong knowledge of Quality Management Systems (QMS) and applicable regulatory standards such as 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 process consistency across teams
• Proficiency in Microsoft Word, Excel, PowerPoint, Teams, and SharePoint
• Preferred German language proficiency (written and verbal)
• Ability to work flexible hours accommodating German time zones

System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

Ref: #558-Scientific