Associate Quality Engineer

1 month ago

Galway, Ireland Abbott Laboratories Full time

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 113,000 colleagues serve people in more than 160 countries.

Abbott serves the Irish market with a diverse range of healthcare products including diagnostics, medical devices and nutritionals products. In Ireland, Abbott employs over 5,000 people across ten 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.

Abbott Rapid Diagnostics is part of Abbottâs Diagnostics family of businesses, bringing together exceptional teams of experts and industry-leading technologies to support diagnostic testing which provides important information for the treatment and management of diseases and other conditions. IDEM is an over a billion-dollar business unit that now support significant growth for Abbott in COVID-19 related products in over 70+ countries

The role:

The Associate Quality Engineer provides a support role to the Quality Manager in the routine maintenance of Abbott RDxâs Quality and other business Management Systems. The Associate Quality Engineer reports to the Senior Quality Engineer at Abbott RDx.

Essential Duties and Responsibilities (Key Activities):

  • Carries out duties in compliance with established business policies and procedures.
  • Demonstrates commitment to the development, implementation and effectiveness of applicable Quality Processes as per ISO, FDA, and other regulatory agencies.
  • Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the companyâs policies and practices.
  • Responsibility to understand and maintain awareness of the quality consequences which may occur from the improper performance of their specific job.
  • Perform other duties and projects as assigned.
  • Possesses and applies a fundamental and increasing knowledge of Quality, and its application within Alere, to the completion of routine assignments.
  • Works in compliance with established procedures and/or protocols. Identifies and resolves readily identifiable, clearly-defined problems.  Demonstrates skill in data analysis techniques by resolving missing/incomplete information in routine assignments.
  • Administration and Organization of the QA Mailbox including recognizing where escalation points are required.
  • Compliant distribution â QA approval of Product supporting the interface between commercial organizations/ distribution business and Legal Manufacturers.
  • Compliant warehousing and handling â QA approval of Product disposition supporting the interface between Warehouse Inventory Control and Legal Manufacturers
  • Continuous improvement - Administration and support of the CAPA/ NC process through weekly continuous improvement meetings.
  • Escalation point for quality-related non-conformances and CAPAs.
  • Execution of product recalls and customer notifications supporting the interface between commercial organisations and Legal Manufacturers.
  • Cross-functional Team member â represents QA in cross-functional teams where business needs require.
  • Support QA structure for Abbott RDx Galway activities.

Education / Experience / Skills

  • Minimum 1 yearsâ experience in medical device industry, including;
  • Competent working knowledge of recognized Quality Management Systems (e.g. ISO9001/ ISO13485/ ISO14971/ GMP),
  • Awareness of relevant laws and regulations (e.g. CE/ FDA/ PAL)
  • Competency in conducting technical review of all documentation/ communications.
  • Broad knowledge of engineering and technical applications applied in development of medical devices useful.

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