Process Manager

About the Company

About the Role

Responsibilities

• 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).
• Manage and maintain documentation related to process validations, deviations, NCRs, and change controls.
• Train and mentor junior engineers and technicians on sterilization and related manufacturing processes.
• Support audits and inspections by regulatory bodies and customers.

Qualifications

Required Skills