Sterilization and Quality Assurance Manager

hace 5 días


Ciudad Guayana, Estado Bolívar, Venezuela Jabil Circuit A tiempo completo

Job Summary

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The Sterilization and Quality Assurance Manager is responsible for supervising and maintaining activities related to the control of the sterilization process of medical products, environmental control of clean rooms, as well as control of semi-controlled rooms dedicated to the manufacturing of medical products.

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Main Responsibilities

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  • Supervise the activities of your team in the environmental control and sterilization area, ensuring compliance with the procedures of the Quality System and applicable international standards.">
  • Promote continuous improvement in the plant by applying environmental assessment techniques related to process improvements and maintenance of the Quality System.">
  • Responsible for maintaining all ethylene oxide chambers revalidated and follow up with the customers when such revalidations must be performed.">
  • Evaluate the root cause of sterilization and environmental control problems both at local facilities and from customer complaints through the corrective action system and provide support with the departmental teams associated with your areas of responsibility.">
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Requirements

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A professional in the area of science, chemistry, Microbiology, Chemistry engineering or any of the chemical or biological sciences preferably. Knowledge of sterilization and environmental standards ANSI AMMI ISO 11135, ANSI AAMI ISO 11137 and ISO 14644. Current knowledge of QSR-21 CFR Part 820, ISO 13485 Quality System standards.

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Bonus Information

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This role requires a high degree of cultural sensitivity due to the multinational mix of the workforce.



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