ALIGN TECHNOLOGY

Solicita: Incoming Inspection Coordinator

• Descripción y Requisitos

  Purpose
  The incoming inspection coordinator is responsible for overseeing the incoming inspection process for materials and components used in Align Technology’s manufacturing operations. This role ensures that all inspection activities comply with applicable procedures, specifications, and regulatory requirements, including FDA GMP/QSR and ISO 13485. The coordinator leads the incoming inspection team, manages inspection-related projects, and ensures that materials are evaluated and accepted in accordance with pre-established inspection plans and quality standards.
  
  Essential Duties and Responsibilities:

  • Ensure all incoming inspection activities comply with ISO 13485, FDA 21 CFR Part 820, and other applicable global regulatory requirements (e.g., MDSAP)
  • Maintain effective communication with Align Mexico management regarding the status, performance, and outcomes of the incoming inspection process.
  • Define and monitor key performance indicators (KPIs) for the incoming inspection process; identify trends, failures, and opportunities for improvement.
  • Lead the development, implementation, and maintenance of procedures related to incoming inspection, ensuring alignment with current regulatory expectations.
  • Provide support to validate and identify measurement equipment and tools to support inspection activities across Align’s Mexico facilities.
  • Ensure that all incoming inspection personnel are properly trained and certified to perform inspections in accordance with component specifications and quality standards.
  • Oversee the acceptance and documentation of materials and components through designated inspection personnel.
  • Interpret Material Safety Data Sheets (MSDS) to establish appropriate handling, storage, emergency response, and waste management procedures for chemical materials.
  • Lead and manage inspection-related projects, including implementation of new inspection methods, equipment upgrades, and process improvements.
  • Coordinate cross-functional initiatives with R&D, Manufacturing sites, and Quality Engineering to ensure alignment on inspection requirements and execution.

  
  
  Education, Skills, and/or Experience Desired:

  • Bachelor’s degree in Industrial Engineering, Electronics, Mechanical Engineering, or a related field.
  • Minimum of 6 years of experience in a quality engineering or inspection role, with strong knowledge of sampling plans and acceptance criteria.
  • Experience in project management or leading cross-functional initiatives is highly desirable.
  • Certifications such as Six Sigma or ASQ (CQE, CQT) are preferred.
  • Proficiency in Microsoft Office (Excel, Word, PowerPoint).
  • Valid Mexican visa and passport.
  • Willingness and availability to travel as needed.

  Specific Language Requirements:
  

  • Advanced English proficiency required (written and verbal), with the ability to communicate effectively across global teams and document technical procedures in English.
  
  

  Puesto: Administracion

• Información Adicional

  Tipo de contrato: Permanente
  Salario: Negociable

  Pais:MEXICO
  Estado o Region: Chihuahua
  Ciudad: Ciudad Juarez