Description
A large Medical Device company, based in Ireland, is seeking a Microbiologist Sterilisation Engineer to join as part of the Global Sterilisation team, to support the internal audit program and lead projects.KEY RESPONSIBILITIES:
• Management of the sterilisation programme, including validation and re-validation of contract sterilisation.
• Performing new product assessments against sterilisation and residual gas requirements in relevant standards.
• Implementing regulatory requirements in accordance with quality standards.
• Completing appropriate sterilisation requirements as part registration of products in various markets.
• Preparation, execution and analysis of related Quality documentation.
• Involvement and general support to the engineering group including execution of assigned projects.
• Ensure that the Code of Conduct is considered with in all business matters carried out on the company’s behalf.
QUALIFICATIONS/REQUIREMENTS
• Third level Qualification in Microbiology with extensive experience in a similar role.
• ETO Sterilisation experience is an advantage for this role
• Thorough knowledge and experience of a regulated industry, including GMP, GDP, GLP and medical device quality standards/practises or similar regulated industry such as ISO10993, EN550, EN ISO and .
• Working knowledge of regulatory requirements, CAPA, NCR and deviation process
• Good communication both written and verbal and good inter-personal skills.
• Willingness to travel on company business
Please apply today with a covering letter highlighting your key skills and relevant experience aligned to this opportunity.