Quality Engineer

hace 3 semanas


Paraíso, Paraíso, Costa Rica Coloplast A tiempo completo

About the Role:

Coloplast is seeking a Quality Engineer to join our team in Cartago, Costa Rica. This is a permanent-full time position that offers a range of benefits, including medical insurance, association, gym, cafeteria subsidy, free transportation, and more.

Main Responsibilities:

  • Develop and implement robust quality control processes to ensure safety and reliability of Coloplast products.
  • Handle non-conforming products, including control of returned goods, reporting in NC system, and handling of lot status in ERP.
  • Create and maintain quality-related documentation in alignment with corporate procedures.
  • Quality approval and release of products in ERP system.
  • Conduct thorough risk assessments and implement risk mitigation strategies to address potential hazards.
  • Handle the full CAPA process, including risk assessment, deep root cause investigations, and evaluation of effectiveness of actions.
  • Ensure regulatory compliance by adherence to requirements (MDSAP, MDR, ISO, FDA, etc.).
  • Support implementation of new machines and item transfers with quality-related tasks.

Requirements:

  • Minimum bachelor's degree in Chemical or Materials Engineering, or equivalent, or minimum 3 years of relevant experience within medical device manufacturing.
  • 1 year of experience within medical device manufacturing.
  • English (minimum B2 level) reading, writing, and speaking in a conversational level.

About Coloplast:

Coloplast is committed to being an inclusive organization, where people bring their differences to work each day, fulfill their potential, and have a strong sense of belonging because – and not despite – of their differences. We therefore encourage all qualified candidates to apply regardless of gender, age, race, nationality, ethnicity, sexual orientation, religious belief, or physical ability.



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