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Manager, Management Consultant
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Oversee and manage all aspects of the sterilization process, ensuring adherence to safety, quality, and regulatory standards.
Lead the development, validation, and continuous improvement of sterilization processes including ETO, Gamma, Steam, or Hydrogen Peroxide.
Collaborate with cross-functional teams (QA, R&D, Production, Regulatory) for successful technology transfers, process validations (IQ/OQ/PQ), and CAPA implementation.
Monitor and analyze process metrics, identifying trends and implementing corrective actions to improve efficiency, yield, and compliance.
Ensure regulatory compliance with applicable standards (ISO 13485, ISO 11135/11137/17665, FDA CFR 21, EU MDR).
Support audits and inspections by regulatory bodies and customers.
Qualifications : Minimum of 7 years in operations or manufacturing, including hands-on experience managing sterilization processes.
Experience with sterilization processes (e.g., ETO, Gamma, Steam, H2O2), strong understanding of regulatory compliance, and ability to lead process improvement initiatives.
