The Sterilization and Environmental Control Quality Manager supervises and maintains activities related to the control of the sterilization process of medical products, environmental control of clean rooms, as well control of semi-controlled rooms dedicated to the manufacturing of medical products, defining strategies aligned with the philosophy and policies of the organization to achieve compliance with procedures, standards and specifications. Also is responsible for the validation activities related to the sterilization cycles and product disposition post-sterilization of the EO chamber. Minimum Requirements 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. Internal auditor, preferred. Quality Engineer certified by the American Society of Quality, preferred. Biomedical auditor certified by the American Society of Quality, preferred. Certified Six Sigma Green Belt or above, preferred. Lead auditor in ISO 13485 and clinical testing laboratory standards, preferred. Ability to work independently, with minimal supervision or in a team environment. High degree of cultural sensitivity due to the multinational mix of the workforce.
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