Document Control and ISO Coordinator
Core
Maintain and improve the facility's Quality Management System (QMS) in accordance with ISO 9001 requirements, coordinate internal audits, and manage controlled documentation.
Role type
Quality Management System (QMS) and Document Control Coordinator
Builds
Quality system records, audit schedules, and controlled document repositories
Domain
Manufacturing / Quality Assurance
Required skills
ISO 9001 compliance, internal audit coordination, document control processes, corrective and preventive action (CAPA) support, quality record management, Microsoft Office proficiency
Preferred skills
ISO 9001 Lead Auditor certification, experience with electronic document management systems, Lean Manufacturing or Six Sigma methodologies, root cause analysis
Technologies
Microsoft Office (Excel, Word, PowerPoint, Outlook), electronic document management systems
Responsibilities
Maintain and administer the Quality Management System (QMS) in accordance with ISO 9001 requirements; Develop, maintain, and coordinate internal audit schedules; Maintain document control processes for SOPs, SWIs, forms, policies, and quality records; Support corrective and preventive action (CAPA) processes; Coordinate communication of document revisions and quality system updates
Seniority
Mid-level, hands-on IC