• Senior Sterilisation Engineer

    Requisition ID
    2018-5363
    Job Location(s)
    Limerick Ireland
    Company
    Cook Ireland
    Position Type
    Full Time
    Category
    Engineering
    Education
    Bachelor's Degree
  • Overview

    The primary purpose of this position is for the Management of the sterilisation programme at Cook Medical.

    Responsibilities

    • Responsibility for the Management of the sterilisation programme at Cook Ireland including validation and re-validation of contract sterilisation.
    • Responsible for Sterilization related queries associated with internal and external audits at COOK Ireland..
    • Performing product assessment against microbiology requirements in relevant standards.
    • Become part of the Cook Global Sterilisation team and lead projects.
    • Responsibility for implementing regulatory requirements in accordance with ISO13485, MDD 93/42/EEC and FDA QSP 21CFR Part 820.
    • Responsibility for completing appropriate sterilization requirements as part registration of Cook products in various markets.
    • Preparation, execution and analysis of related Quality documentation.
    • Ensure that Cook’s Code of Conduct is considered in all business matters carried out on Cook’s behalf.

     

    Qualifications

    • Third level Qualification in Microbiology with at least 5 years experience in a similar role (relevant experience in same with equivalent third level Science Qualification will be considered).
    • ETO Sterilisation experience is essential for this role.
    • A strong knowledge of biocompatibility is desirable.
    • Thorough knowledge and experience of a regulated industry, including GMP, GDP, GLP.
    • Knowledge of medical device quality standards/practises or similar regulated industry such as ISO10993, EN550, EN ISO 11135-1 and 11737-1.
    • Knowledge of regulatory requirements.
    • Good knowledge of CAPA, NCR and deviation process.
    • Good communication both written and verbal and good inter-personal skills.
    • Proven problem-solving skills.
    • Good computer skills including knowledge of Microsoft®
    • Proven organisational skills.
    • High self-motivation and proven team member skills.
    • Willingness and availability to travel on company business.

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