Medical Device Validation Engineer

hace 17 horas


San José, San José, Costa Rica Gsb A tiempo completo

Job Overview:

We are seeking a highly motivated and experienced Validation Engineer to join our team at Gsb. As a key member of our organization, you will be responsible for ensuring the quality and safety of our medical devices.

About the Role:

  • Develop and implement validation strategies to ensure compliance with regulatory requirements.
  • Liaise with cross-functional teams to identify and mitigate potential risks.
  • Conduct site audits and evaluations to ensure adherence to GMP and ISO 9000 standards.
  • Analyze data and provide recommendations for process improvements.

Responsibilities:

  • Conduct meetings with cross-functional teams to develop strategies and solutions.
  • Guide the validation process and lead the writing and review of test protocols and reports.
  • Offer on-site support during the validation execution phase (IQ, OQ, PQ).

Requirements:

  • 4+ years of experience in validation engineering, preferably in the medical device industry.
  • Demonstrated knowledge of GMP, ISO 9000, and regulatory affairs.
  • Ability to communicate effectively with stakeholders at all levels.


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