QMS System Lead - Doc Control

QMS System Lead - Doc Control#26-01013 $0-$56 per hour Chicago, IL

Fully Remote Job Description At-a-Glance:

Are you ready to build your career by joining a certified technology solutions and compliance consulting services company? If so, our client is hiring a QMS System Lead - Doc Control.

Position Type:

Contract Remote

Required:

Bachelor's degree in a technical or scientific discipline, or equivalent experience in quality systems within a regulated industry. 8+ years of experience in Quality Management Systems, preferably within the medical device industry. Deep expertise in document control processes, systems, and tools in regulated environments. Demonstrated knowledge of

FDA 21 CFR 820, ISO

13485, and other applicable global regulatory requirements for document control. Experience supporting QMS remediation initiatives, audits, inspections, or regulatory findings related to document management systems. Strong analytical, technical writing, and communication skills, capable of preparing regulatory-ready documentation and executive-level updates. Proven ability to lead cross-functional teams and manage multiple workstreams across sites, driving remediation and sustainable compliance.

Responsibilities:

Serve as the Subject Matter Expert (SME) for Document Control processes, providing guidance on regulatory requirements, best practices, and system improvements. Lead the Document Control Workstream within the QMS remediation program to address compliance gaps and enhance document management systems. Support CAPA investigations and remediation activities, including root cause analysis, risk assessment, and development of sustainable corrective actions. Implement and monitor interim controls and risk mitigation measures to maintain compliance until permanent solutions are validated and executed. Lead or support the redesign, remediation, and implementation of Document Control procedures, systems, and records to ensure alignment with global regulatory standards. Develop and maintain metrics, dashboards, and reporting tools to monitor remediation progress, document control effectiveness, and continuous improvement initiatives. Provide training, mentorship, and cross-functional guidance to strengthen adherence to Document Control processes and promote a culture of quality and compliance. Get in

Touch:

We want to hear from you! If you think you'd be a good match, submit your resume and reach out to Komal at 862-390-7418 to learn more. #LI-VK1 #HbM6349