Quality Assurance Specialist 2 - Limerick - TN Ireland

    TN Ireland
    TN Ireland Limerick

    6 days ago

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    Description

    Job Title

    Quality Assurance Specialist 2, Limerick

    About the Role

    This role is responsible for providing Quality Assurance support within Cook Medical Europe Ltd. (CMEU).

    Key Responsibilities

    • Maintain an active oversight of the CMEU Quality Management System (QMS) to ensure it is fit for purpose and compliant with procedures, regulations, and best practices.
    • Maintain the internal audit system in CMEU, acting as the Quality Internal Auditor with a team of Internal Auditors.
    • Conduct in-depth internal audits of all aspects of the QMS against relevant regulations, working collaboratively with stakeholders to achieve zero non-conformances within CMEU.
    • Maintain a detailed and up-to-date knowledge of medical device regulations, guidance, and requirements relevant to Quality Assurance.
    • Organise and manage site preparation and manage audit back rooms for Regulatory and Corporate Audits.
    • Provide Quality Assurance support to all areas of the QMS, ensuring compliance is maintained at all times.
    • Identify, lead, and drive QA process improvement initiatives as appropriate.
    • Prepare, implement, and analyse key Quality Systems related documentation.
    • Maintain and support the Corrective and Preventive Action (CAPA) program.
    • Maintain and support the Non-conformance program.
    • Delegate for the Manager, Quality Assurance, CMEU.
    • Provide training on the CMEU Quality Manual and other key Quality Systems procedures as required. Provide inputs to KPIs and Management Review.
    • Prepare Management Review presentations as appropriate.
    • Provide meaningful Quality Assurance measurement while ensuring that in-house or external Quality issues are effectively prioritised and acted upon in a timely manner.
    • Ensure that Cook's Code of Conduct is considered in all business matters carried out on Cook's behalf.

    Requirements

    • Third Level qualification in Quality, Science, Engineering, or other relevant technical discipline.
    • Knowledge and experience (min 4 years) of working with ISO13485, ISO14971, the Medical Device Directive, the FDA QSR including 21 CFR Part 820 and 21 CFR Part 11, Regulation (EU) 2017/745 (EU MDR) and other Regulations applicable to EMEA regions, ideally gained in the medical device industry.
    • Qualified and experienced Lead Auditor, preferably within the medical device industry.
    • Good working knowledge of Microsoft Office, desirable.
    • Strong interpersonal skills with the proven ability to communicate effectively at all organisational levels.
    • Demonstrable ability to challenge/influence thinking/opinion/actions with the aim of ensuring CMEU QMS is adhered to.
    • High attention to detail.
    • Excellent organisational skills, with the ability to manage own time effectively.
    • High self-motivation, with a proactive, solution driven approach to problem-solving.
    • Willingness and availability to travel on company business if required.
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