Quality Assurance Expert

hace 6 horas


San José, San José, Costa Rica Theragenics Costa Rica Ltd. A tiempo completo

About the Role:

Theragenics Costa Rica Ltd. is seeking a highly skilled Senior Quality Engineer to provide expert quality assurance support to our production processes, initiatives, and projects.

Key Responsibilities:

  • Lead and/or support process, product, and equipment validation transfers, and design process activities.
  • Execute equipment and process validation activities as required.
  • Review and ensure validation protocols, as well as monitor quality policies regarding the transfer and validation processes of processes/products.
  • Resolve product quality issues and support implementation or transfers of new products by reviewing quality, testing plans, and quality transfer strategies.
  • Travel and carry out evaluations of new products at the level of product quality risks as well as the transfer and validation strategy.

Requirements:

  • Bachelor's degree in engineering or any related discipline field (required).
  • Working knowledge of the quality system regulation (21CFR PART 820) and ISO 13485 requirements.
  • Professional fluency in English is required (B2 - C1), both written and oral.
  • At least five years of experience in medical device environment is required.
  • Knowledge of statistical analysis tools and familiarity with equipment and process validation (required).
  • Proven previous experience working with Minitab (required).

About Us:

Theragenics Costa Rica Ltd. is a leading [industry] company dedicated to delivering high-quality products and services. Our team is committed to excellence and innovation, and we are looking for talented individuals who share our values to join us on this journey.



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