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Santiago, 8320000, CL
Job details
Work flexiblity: Hybrid
Req ID: R528792
Employee type: Full Time
Job category: RAQA
Travel: 20%
Relocation: No
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Job description
What You Will Do
- Implement, monitor, and oversee quality processes related to operations in Chile, focusing on logistics, warehousing, kitting, and transportation, ensuring 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.
What You Will Need
- Bachelor’s degree in engineering or related
- 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.