1+ months

Auditor (Quality)

Donegal, Donegal

Abbott serves the Irish market with a diverse range of health care products including diagnostics, medical devices and nutritional products.

In Ireland, Abbott employs almost 4,000 people across nine sites. We have six manufacturing facilities located in Clonmel, Cootehill, Donegal, Longford and Sligo and a third-party manufacturing management operation in Sligo. Abbott has commercial, support operations and shared services in Dublin and Galway. We have been operating in Ireland since 1946.

The Role:

In the role of Quality Engineer (Auditor) you will lead a comprehensive Quality Audit Service at the Abbott Diabetes Care (ADC) Donegal site; ensuring compliance to the ADC QMSM and the Corporate, Division, Site and worldwide regulatory requirements that apply to ADC Donegal. As the site Auditor you will be focused on Internal Audits, Focus Audits and External Audit management.

Major Responsibilities include:
  • Responsible for the Global Audit program at the ADC Donegal site.
  • Build positive relationships and coordinated communications to site leadership team.
  • Lead all scheduled internal, external and focused audits ensuring integrity and compliance with auditing requirements.
  • Support the CAPA process by reviewing and approving all related CAPA audit activities.
  • Track and Trend Audit related data as required.
  • Site metric owner for any Audit metrics and KPI’s.
  • Collaborate with the Division Manager in developing Auditor training, maintain awareness of changes to applicable standards and regulations and implement improvements.
  • Maintain a high awareness of industry developments, particularly in the area of audit compliance and FDA communications.
  • Provide status updates to relevant functions/external agencies on any observation and concerns noted and ensure timelines committed are met and audits/inspections closed.
  • Responsible for compliance with applicable Corporate and Divisional policies and performing other duties as assigned by management.

    Education and Background:
    • Certified Lead Auditor (ISO 13485)
    • A relevant third level qualification in Quality/Engineering/Manufacturing/Science.
    • 2 years’ relevant experience in a Quality/Engineering/Manufacturing/Science environment.

      Abbott is an equal opportunities employer.

        ","title":"Auditor (Quality)Division: ADC Diabetes Care
        Travel: Yes, 5 % of the Time
        Medical Surveillance: Not Applicable
        Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)


Posted: 2019-09-04 Expires: 2019-11-06

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Auditor (Quality)

Donegal, Donegal

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