Job ID: JOB-11581
Our client, a medical device company is recruiting for an Sterilisation Specialist for their site in Mayo. This role is commutable from Sligo and Roscommon. This role is within the Compliance group in Quality.
The purpose of the position is to provide sterilization assurance for the products and so contribute to the growth and profitability of the company.
- Perform testing and data collection for sterile products, verifying the sterilization process meets recognized standards.
- Coordinate sample sterilization for material evaluation studies.
- Assists with the integration of new technologies, methods, and processes.
- Coordinate dose auditing activities for current products sterilized by radiation.
- Gather and graph product bioburden data to determine trend development or out of limits results.
- Complete annual review of sterile product families, interpret the results and communicate in compliance with standard requirements.
- Gather and graph data collected for cleanroom monitoring to determine trend development or out of limit results.
- Support cleanroom isolate characterization activities.
- Assist in investigations related to contamination control or microbiological issues.
- Provide training to associates working in and around the clean room environment.
- Assist in External Audits (NSAI, FDA).
- 3-5 years of relevant work experience in the field of sterilization engineering, sterilization microbiology or similar
- Bachelor’s Degree in Microbiology, Biology or related study
Specialized Skills/Technical Knowledge:
- Demonstrates knowledge of ISO Sterilization Standards (i.e. ISO 11137-1, 11137-2, 11737-1, 11737-2).
- Experience in sterilization processes, microbiology (bioburden and sterility testing), and environmental monitoring
- Working knowledge of ISO13485 or ISO9001
- Good technical capabilities, communication skills, teamwork abilities and initiative
- Continually seeks to drive improvements in quality systems, products and processes.
- Willing to be open to change and support and champion change
- Excellent ability to deliver results, with strong interpersonal, communication and influencing skills
- Proficient computer skills, including Microsoft Office Suite (Word, PowerPoint, Project, Access and Excel).
For further information on Sterilisation Specialist role in Mayo please contact Clara Burke on 086 8168273 / email@example.com
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