Quality Engineer

Detalles de la oferta

Quality Engineer with a strong background in sterilization processes, specifically gamma radiation. Have hands-on experience in the validation, testing, and monitoring of sterilization procedures, with a focus on ensuring compliance with industry standards and regulatory requirements. This role involves working closely with cross-functional teams to drive quality improvements and maintain high standards for product safety and performance.

Responsibilities:

Develop, implement, and validate sterilization processes, with a primary focus on gamma radiation sterilization.
Ensure compliance with regulatory standards such as ISO 11137, ISO 13485, and FDA requirements.
Perform risk assessments and manage sterilization validation projects from design to execution.
Conduct PQ, IQ and OQ testing for sterilization equipment.
Requisitos:
Bachelor's degree in Engineering (Biomedical, Chemical, Mechanical, or related field).
3-5 years of experience in a quality engineering role with a focus on sterilization processes, especially gamma radiation.
Strong understanding of sterilization principles, validation processes, and regulatory standards.
Experience with ISO 11137, ISO 13485, FDA regulations, and other industry standards related to sterilization.
?Proficiency with quality tools such as root cause analysis, failure mode effect analysis (FMEA), and statistical process control (SPC).
Experience with sterilization equipment (gamma irradiators, biological indicators, etc.) and data analysis.


Salario Nominal: A convenir

Fuente: ClasificadosOnline

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