Staff Specialist, Quality Management Systems
Hybrid in Cary, IL
Pay: $55.87/hr.
Duration: 12 months, Contract, W-2
Shift: M-F 8:00 AM - 5:00 PM with flexibility to accommodate German local working hours
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). 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
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