Senior Quality Operations Manager

hace 2 semanas


Santiago, Metropolitana, Chile Stryker Chile LTDA A tiempo completo

Role Overview

The Senior Quality Operations Manager will be responsible for implementing, monitoring, and overseeing quality processes related to operations in Chile, focusing on logistics, warehousing, kitting, and transportation, ensuring alignment with ISO 13485 standards and regulatory compliance.

Key Responsibilities

  • Implement and monitor quality processes to ensure alignment with ISO 13485 standards and regulatory compliance.
  • Lead the resolution of non-conformities and collaborate on process improvements within the operations area to meet quality and efficiency standards.
  • Ensure that all operational activities, including kit assembly, follow standard procedures and meet regulatory and customer expectations.
  • Collaborate closely with operations, logistics, and sales teams to drive quality-related initiatives, maintaining strong cross-functional relationships.
  • Work with quality leadership to ensure effective decision-making and ongoing compliance with ISO 13485 standards across all operational processes.
  • Develop and maintain quality systems, providing guidance on their implementation to ensure operational processes align with quality assurance and regulatory requirements.
  • Support the development and delivery of quality training programs, ensuring that all operational staff are well-versed in and adhere to quality standards.
  • Identify opportunities for process improvements within the operations area, driving continuous improvement initiatives to enhance quality, service, and operational efficiency.

Requirements

  • Bachelor's degree in engineering or related field.
  • Ability to work independently with minimal supervision.
  • Previous experience in Quality Control Positions.
  • Advanced English skills required.
  • Previous Experience in Medical Devices, Pharmaceutical or Automotive companies.
  • Strong knowledge and experience with ISO 13485 standards.

Travel Percentage

20%



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