Medical Device Quality Engineer

hace 3 días


San Francisco, Heredia, Costa Rica Viant Costa Rica A tiempo completo

Viant Costa Rica Overview

We are a leading manufacturer of medical devices, and we are looking for a dedicated Quality Engineer to join our team. As a Quality Engineer, you will play a critical role in ensuring the quality and safety of our products.

Job Description:

The Quality Engineer will be responsible for providing quality engineering support to the development and production of Class I, II, and III Medical Devices. This includes:

- Providing quality engineering support to ensure compliance with FDA, ISO, and other applicable regulations.

- Collaborating with cross-functional teams to develop and implement quality plans, process validations, and FMEA/Risk Analysis.

- Conducting finished goods variance investigations, complaint resolution, process improvement, and quality assurance testing methodologies.

- Participating in or leading Corrective/Preventive Action initiatives.

- Supporting internal/external audits, vendor qualification, and training programs.

Requirements:

- Bachelor's degree in Engineering or Science (such as Pharmacy, Microbiology, Physics, or Chemistry).

- Bilingual English/Spanish - Advanced English level (written and spoken).

- Knowledge of applicable regulations for the medical device industry (FDA, ISO, etc.).

- At least 2 years of work experience in manufacturing environments is preferred.

Key Responsibilities:

  • Provide quality engineering support to ensure compliance with FDA, ISO, and other applicable regulations.
  • Collaborate with cross-functional teams to develop and implement quality plans, process validations, and FMEA/Risk Analysis.
  • Conduct finished goods variance investigations, complaint resolution, process improvement, and quality assurance testing methodologies.


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