Quality Assurance Specialist

hace 1 semana


Tijuana, Baja California, México Ws Audiology A tiempo completo

**Job Summary**

We are seeking a highly skilled Quality Assurance Specialist to join our team at Ws Audiology. As a key member of our Global Quality Team, you will be responsible for ensuring that customer complaints are captured, assessed, and resolved in a timely manner.

Main Responsibilities:

  • Participate in Global Projects and improvements related to complaint handling processes.
  • Be a key contact person for stakeholders and ensure that Global complaint process inspections and Audits (internal and external) are prepared and covered on local market.
  • Perform follow-ups with investigators/LPoC/others to ensure complaints are processed in a timely manner.
  • Continuously review complaint files to ensure documentation is performed according to requirements (internal/external) and in line with GDP needs.
  • Perform initial screening of new complaints to determine potential reportability, investigator, and appropriate investigation location.

Requirements:

  • Working experience in complaint handling and customer quality required.
  • Knowledge of Operational processes.
  • Experience in complaint handling processes for medical devices.
  • Knowledge of FDA regulations, ISO13485.
  • Ability to actively participate and present during External/internal Audits, FDA Inspections.

What We Offer:

  • Permanent contract.
  • Full-time position.
  • Competitive salary and benefits package.

Language Requirements:

  • English: Spoken: 90%, Written: 90%.


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