Align Technology-posted 3 months ago
Senior
San Jose, CA
5,001-10,000 employees
Miscellaneous Manufacturing

The Senior Packaging and Labeling Product Engineer will lead critical packaging and labelling initiatives. This role is essential for driving compliance, innovation, and operational excellence for Global Medical Device. If you have expertise in quality systems, regulatory compliance, project management, and process improvement, we want to hear from you. This role will be located in San Jose, CA and have no direct reports.

  • Maintain and enhance packaging and labelling quality systems in compliance with Global Regulatory and Legal requirements.
  • Develop and refine SOPs, work instructions, and other quality documentation.
  • Lead change management for packaging and labelling, ensuring smooth implementation of lifecycle changes.
  • Review and manage label change requests (LCR) to ensure compliance and timely updates.
  • Manage packaging and labelling initiatives from concept to implementation.
  • Develop scopes, timelines, and risk mitigation strategies to ensure compliance with regulatory standards.
  • Identify opportunities for efficiency within labelling workflows and implement best practices.
  • Drive continuous improvement to enhance compliance, productivity, and cost-effectiveness.
  • Provide expertise in root cause analysis and corrective actions for packaging and labelling issues.
  • Ensure specifications meet regulatory and process standards.
  • Collaborate with quality assurance, regulatory affairs, manufacturing, engineering, operations, product management, PMO, and supply chain teams.
  • Support product launches and regulatory updates to achieve timely and compliant product releases.
  • Expertise in quality systems.
  • Knowledge of regulatory compliance.
  • Experience in project management.
  • Skills in process improvement.
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