Sterilization Engineer

6 days ago

Singapore Fong’s Engineering & Manufacturing Pte Ltd Full time

**Engineer, Sterilization**
**JOB RESPONSIBILITIES**
- Perform qualification validation of EtO sterilization related equipment and processes
- Perform the release of sterilization batches in accordance to ISO11135
- Ensure the compliance of equipment in accordance to Calibration and Preventive Maintenance

requirements.
- Perform complaint handling, investigate root cause of complaint and perform Corrective Action and

Preventive Action as necessary.
- Handle non-conformances and perform disposition of rejected parts, trend yield and rejects, investigate root

cause of non-conformance and perform Corrective Action and Preventive Action as necessary.
- Initiate and/or execute engineering changes in compliance with Engineering Change Control procedures
- Participate in Process Failure Mode Effect and Analysis team to mitigate product risk arising from

manufacturing
- Participate in external and internal audit to ensure company quality system is effective
- Participate in continuous improvement programs such as 6S program, yield improvement projects etc.
- Support new production introduction as a team member representing quality
- Perform other tasks as assigned by the supervisor

**Requirements**:

- Bachelors Degree in Engineering, Science (e.g. Microbiology) or equivalent
- Work experience as a sterilization engineer in a medical device manufacturing environment
- Experience with qualification validation of equipment and processes for sterilization of medical device
- Working knowledge of ISO11135 EtO Sterilization for Medical Devices
- ISO13485 Internal auditor
- Statistical Analysis (Hypothesis Testing, ANOVA, Gage R&R, DOE etc)
- Root cause analysis (Kepner-Tregoe, 5-Why, 6M etc)

If you are looking for challenges and have the qualities and experience to undertake this challenging opportunity,

expected salary, and notice period.

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