- Perform qualification validation of medical device sterilization related equipment and processes
- Perform the release of sterilization batches in accordance to relevant ISO standards
- 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
Education
- Bachelors Degree in Engineering, Science (e.g. Microbiology) or equivalent
Experience
- 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 and/or any other relevant standards such as ISO11137 Gamma Sterilization
- ISO13485 Internal auditor
Skills
- Statistical Analysis (Hypothesis Testing, ANOVA, Gage R&R, DOE etc)
- Root cause analysis (Kepner-Tregoe, 5-Why, 6M etc)
- Problem solving techniques (e.g. DMAIC/8D/PDCA/A3 application in continuous improvement)
- Competent with general PC and Office software application
