• Quality Systems Engineer

    Requisition ID
    2018-4655
    Job Location(s)
    Limerick Ireland
    Languages Required
    English
    Travel
    Less than 10%
    Company
    Cook Ireland
    Position Type
    Full Time
    Category
    Quality
    Education
    Bachelor's Degree
  • Overview

    The primary function of this role is to maintain the Internal Audit System at Cook Medical and Cook Medical Europe CMEU, and to act as Quality Auditor. The responsible person will also assist in the implementation and improvement of all aspects of the quality management system (QMS).

    Reporting to: Quality Systems Manager  

    Find out more about Cook Medical here

    Responsibilities

    • Maintain the Internal Audit System at Cook Medical and CMEU acting as the Quality Auditor with a team of Internal Auditors.
    • Conduct in-depth Internal Audits of all aspects of the QMS against the relevant regulations.
    • Detailed knowledge of the Medical Device regulations, guidance and requirements.
    • Ability to implement and improve a QMS
    • Organise and manage site preparation for Regulatory and Corporate Audits.
    • Manage Audit back rooms for Regulatory and Corporate Audits.
    • Provide Quality Systems support to all areas of the QMS, ensuring compliance is maintained at all times.
    • Conduct Supplier audits.
    • Ability to lead and drive assigned Process Improvements essential.
    • Prepare, implement and analyse key Quality Systems related documentation.
    • Provide input and support to the Cook Medical Corrective and Preventive Action (CAPA) program.
    • Provide training on the Quality Manual and other key Quality Systems procedures.
    • Prepare Management Review presentations as appropriate.
    • Provide meaningful Quality measurement while ensuring that in-house or external Quality issues are effectively prioritised and acted upon in a timely manner.
    • Provide inputs to KPI’s and Management Review.
    • Ensure that Cook’s Code of Conduct is considered in all business matters carried out on Cook’s behalf.

    Qualifications

    • Third Level Qualification in Quality, Science or Engineering.
    • Proven knowledge and experience (min 4 years) of working with ISO13485, ISO14971, the Medical Device Directive and the FDA QSR including 21 CFR Part 820 and 21 CFR Part 11, ideally gained in the medical device industry.
    • Qualified and experienced Lead Auditor, preferably within the Medical Device Industry.
    • Strong interpersonal skills with the ability to communicate effectively at all organisational levels.
    • The ability to challenge thinking/opinion/actions in light of ensuring Cook Ireland (CIRL) Quality Systems is adhered to.
    • High attention to detail in all aspects of the role.
    • Excellent organisational skills.
    • Proven problem-solving skills.
    • High self-motivation.
    • Good working knowledge of Microsoft Office.
    • Willingness and availability to travel on company business.

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