Quality Assurance Manager, Medical Devices

hace 1 semana


Tijuana, Baja California, México ICU Medical A tiempo completo

Job Description:

Overview

ICU Medical is seeking a highly experienced Quality Assurance Manager to join our team. As a key member of the Quality organization, you will be responsible for ensuring compliance with regulatory requirements and quality standards.

Key Responsibilities:
  • Develop and implement quality assurance programs to ensure compliance with FDA regulations and ISO 13485.
  • Conduct audits and investigations to identify areas for improvement and provide recommendations for corrective action.
  • Collaborate with cross-functional teams to develop and maintain quality systems and processes.
  • Provide training and guidance to employees on quality procedures and regulatory requirements.
Requirements:
  • 7+ years of experience in quality assurance or a related field.
  • Bachelor's degree in a relevant field such as engineering or life sciences.
  • ASQ CQE or CSQE certification required.

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