Medical Device Quality Engineer
hace 3 días
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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