The Sterilization Engineer be responsible to ensure that sterilization process comply with the specification and regulatory government agencies requirements – FDA, PMDA, ISO 13485. Will lead and participate in the Global Sterilization committee and standardization.
- Lead/participate sterilization process meets specification/requirement, maintenance of sterilization equipment, process and equipment improvement
- Provide support to production for any technical issue and other activities (Nonconformity management, CAPA, training, calibration, maintenance, etc.).
- Collaborate, update and maintain FMEA for sterilization.
- Support, review and approve the following processes:
- Document updates/approvals related to Sterilization
- Routine Sterilization Release
- Corrective / Preventive Actions related to Sterilization
- Work on special projects assigned by Supervisor/Manager.
