Quality Assurance Specialist

hace 7 horas


Bogotá, Bogotá D.E., Colombia UPS A tiempo completo

Job Title: QA Supplier Management and Validation Specialist

Job Summary:

The Quality Assurance Supplier Management and Validation Specialist will assist in the implementation and maintenance of the Quality Management System within the scope of the supplier qualification process and computer system validation (CSV) in alignment with healthcare guidelines and ISO 9001/ISO 13485 requirements.

Key Responsibilities:

  • Support the development, maintenance, and continuous improvement of the Supplier Management & CSV Programs.
  • Conduct risk assessments on the Supplier Management process to identify potential risks and communicate findings to management.
  • Assist with the distribution, follow-up, and evaluation of supplier questionnaires.
  • Prepare and execute supplier audits according to the created supplier audit plan and supplier risk levels.
  • Monitor and trend the outcome of supplier audit findings.
  • Assist with the distribution and completion of supplier technical agreements.
  • Develop and revise procedures to ensure alignment with regulatory guidelines.
  • Develop, execute, and review validation protocols.

Requirements:

  • Bachelor's Degree in a related field.
  • Experience with healthcare regulations and ISO 9001/ISO 13485 standards.
  • Advanced English language skills.
  • Knowledge of Quality Management Systems and Microsoft Office.

UPS is an Equal Opportunity Employer.



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