Jobs

    Quality Specialist - Clare, Ireland - Harmonics

    Harmonics
    Harmonics Clare, Ireland

    1 week ago

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    Description

    Job Summary:

    Our client based in Shannon Clare are a global leader in new technologies and advanced manufacturing methods for the MedTech sector at home and abroad.

    The successful candidate will develop, establish and maintain quality systems and practices which meet the company, customer and regulatory requirements.


    Reporting To:

    Quality Manager Responsibilities:
    Complete DHR reviews to ensure timely release of product. Ensure compliance with all pertinent regulations (e.g. FDA, ISO) Ensuring the promotion of the awareness of customer requirements in the company. Liaising with production in the disposition of product. Support production activities in building quality into SLE products and assuring compliance to the pertinent regulations.

    Ensure compliance and execute activities to the QMS such as non-conformance investigations, CAPA, Change control, complaints, document control, and record retention.

    Develop, implement and maintain procedures and forms. Lead and execute upgrades to the quality system. Participation in the audit system. Support customer and regulatory audits.


    Qualifications/Experience:
    Minimum of 3 years in a Quality Assurance role in Medical Device or Pharma is preferred.

    Excellent verbal and written communication skills Ability to work in a cross functional team Good command of MS Office Word, Excel, PowerPoint Working knowledge and understanding of QSR and ISO quality system requirement Skills:
    MS Office QSR ISO QA
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