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Job

Quality and Compliance Specialist

  • Job ref:

    1170054/001_1574095066

  • Location:

    Tipperary, Republic of Ireland

  • Sector:

    Quality Engineers

  • Job type:

    Permanent

  • Salary:

    €50000 - €55000 per annum

  • Contact:

    Stephanie Willis

  • Email:

    swillis@cbsbutler.com

  • Published:

    25 days ago

  • Start date:

    ASAP

Quality and Compliance Specialist - Co. Tipperary

An experienced Quality and Compliance Specialist is required basis for a client of mine who specialise in a range of Clinical quality control equipment as well as a range of medical devices.

Job Role and Responsibilities:

  • Implement, maintain and ensure compliance to the quality system application within their distribution business (ISO 9001, ISO 13485 and GDP Guideline c2013/C 343/01).

  • Identifies guidance documents, international standards, consensus standards and assists teams with their interpretation.

  • Lead and Manage NCR, CAPA & Change Control process, ensuring all Quality related activities are completed in a timely manner.

  • Manage Complaint/feedback/pharmacovigilance activities as required through Distribution Agreements and regulatory requirements in conjunction with the Sales Department and Suppliers.

  • Review and maintain procedures, polices and other instructional documents with a focus on continuous improvement.

  • Review and approval of protocols, reports, and change management documentation ensuring defendable practices and conclusions.

  • Input and approval of validation/verification projects of equipment and processes.

  • Administration of calibration and preventative maintenance logs and documentation, providing notification of scheduled calibrations, PMs and Services to relevant parties.

  • Manage Risk Management processes. Manage the risk register and the opportunity register.

  • Oversight of internal audit schedule and conduct of internal quality system audits. Perform supplier quality audits where needed.

  • Organise, support and participate in external Audits (HPRA, Certification Body, Customer Audits)

  • Co-ordination of annual management review, minute taking and manage out-coming actions.

Qualifications/Competencies:

  • Level 8 degree qualification in a relevant Science, Engineering or Quality Assurance discipline

  • 5+ years industry experience working in a Quality Assurance regulated medical product environment

  • Thorough knowledge of MDD, MDR, IVDD, IVDR, ISO 9001, ISO13485, GDP Guideline c2013/C 343/01 and other international regulatory requirements.

  • Fluent in English

  • Proficient in Excel, PowerPoint, Visio, Word etc.

  • Strong interpersonal skills and the ability to communicate well, both verbally and in writing, with others.

  • Excellent attention to detail and ability to prioritise