Senior Quality Assurance Engineer

hace 2 semanas


San Francisco, Heredia, Costa Rica Te Connectivity A tiempo completo

About the Role:

We are seeking a skilled Senior Quality Assurance Engineer to join our team at Te Connectivity. In this role, you will be responsible for ensuring the quality and reliability of our products by designing, recommending revisions, and installing quality control systems.

Key Responsibilities:

  • Complete validation activities for label printing systems globally
  • Provide guidance and support to internal and external departments on cGMP requirements and regulatory standards
  • Adhere to regulatory standards such as 21CFRPart820, 21CFRPart11, Annex11, and ISO13485:2016
  • Execute site validation strategies, protocols, and reports ensuring compliance to corporate and regulatory quality procedures and standards

Requirements:

  • Bachelor or master's degree in science, engineering, or software discipline
  • 5 years of related experience, including 3+ years' experience supporting software quality/compliance or software assurance
  • Working knowledge of regional and international quality system requirements
  • Experience with IEC 62304, IEC 82304, GDPR, and ISO 14971 is an advantage


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