QA Specialist

About Abbott

At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 113,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.

Abbott in Ireland

Abbott serves the Irish market with a diverse range of health care products including diagnostics, medical devices and nutritionals products. In Ireland, Abbott employs over 6,000 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 Galway

Abbott in Galway serves as the international hub for Abbott's Rapid Diagnostics business, which delivers annually more than 2 billion tests. As the global leader in point-of-care diagnostics, Abbott offers the broadest portfolio of best-in-class rapid tests, services, and handheld devices across all healthcare settings: the lab, the clinic, remote healthcare outposts, retail outlets, the patient's bedside and at home. Our industry-leading near patient tests and services are unmatched across key health and therapeutic areas, including: infectious disease, cardiometabolic & informatics, toxicology and consumer diagnostics.

One of the key functions in Galway is Global Business Services, which provides number of shared services activities across finance, purchasing, quality, technical and customer services for Europe, Middle East and Africa (EMEA). Various global and EMEA commercial and operational management teams across our infectious disease and cardiometabolic businesses are also based in Galway, overseeing the supply of millions of rapid tests from HIV to diabetes to COVID-19, to patients in many regions across the world.

Purpose of the Job:

The Quality Specialist provides a support role to the Quality Manager in the routine maintenance of Quality and other business Management Systems. Please note this is a 1 year fixed term contract position.

Key Responsibilities:

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 company’s 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 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 – QA approval of Product supporting the interface between commercial organizations/ distribution business and Legal Manufacturers. Compliant warehousing and handling – 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 organizations and Legal Manufacturers. Cross-functional Team member – represents QA in cross-functional teams where business needs require.

Education, Skills & Experience

Minimum 1 years’ 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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