Overview
Skills
Job Details
The Labeling Project Leader will lead and execute the label design change project to ensure compliance with ISO14607:2024 standards. This individual will oversee the end-to-end labeling change process for the Texas site-covering project planning, cross-functional collaboration, regulatory alignment, and lifecycle labeling portfolio management.
Key Responsibilities-
Lead and manage label design change projects and lifecycle labeling activities.
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Act as the primary liaison between labeling, quality, regulatory, engineering, and supply chain teams.
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Develop and implement project plans, risk assessments, and change management documentation.
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Drive cross-functional alignment on scope, regulatory impact, and phase-in/phase-out strategy.
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Supervise internal and external team members executing label changes.
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Represent labeling in design control, CAPAs, and change management activities.
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Ensure all labeling changes meet quality, compliance, and regulatory requirements.
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Support multi-generational planning (MGPP) to meet compliance and cost targets.
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Bachelor's degree in Engineering, Design, or a related discipline.
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5+ years of experience in labeling, operations, engineering, regulatory, or quality within a medical device or regulated industry.
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Strong project management skills (PMP preferred).
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Experience with labeling systems, design control, and change management.
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Proficiency in MS Office, MS Project, Visio, and Adobe Illustrator.
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Working knowledge of PLM and ERP systems (Windchill, Adaptiv, or JDE preferred).
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Familiarity with packaging machinery (Flow Wrap and Cartoning).
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Excellent communication, leadership, and stakeholder management skills.
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Green Belt or Lean Six Sigma certification.
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Experience in new product development (NPD) or lifecycle labeling projects.
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Strong business and financial acumen.
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Experience in medical device labeling compliance and global supply chain processes.
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Up to 5% travel, including occasional international trips (some on short notice).