Quality Systems Compliance Expert

hace 6 días


San José, San José, Costa Rica Genpact A tiempo completo
Job Overview

As a Medical Device Quality Assurance Specialist, you will play a vital role in ensuring the quality and integrity of medical devices. Your responsibilities will include investigating complaints, managing complaint files, and collaborating with internal stakeholders.

About Genpact

Genpact is a global professional services firm that delivers innovative solutions to leading enterprises. Our purpose is to create a world that works better for people, and we achieve this through our expertise in data, technology, and AI.

Key Responsibilities
  • Investigate medical device complaints and events in a timely manner.
  • Manage complaint files, ensuring accurate entry of complaints in databases.
  • Collaborate with internal stakeholders to ensure effective complaint management.
  • Translate documents from Spanish to English or English to Spanish as required.

Required Skills and Qualifications

To be successful in this role, you will need:
  • A Bachelor of Science degree in Engineering or Biomedical Engineering.
  • Medical device experience or a related background (e.g., LPN, Associate RN, X-Ray technician, Biomedical technician, Nurse).
  • Critical thinking and decision-making skills, as well as strong administrative duties, data accuracy, and communication skills.
  • A working knowledge of Medical Device Quality Systems regulations (e.g., ISO 13485, EU-MDR 2017/745, 21CFR820).


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