QMS System Lead - Doc Control

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.

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