PQA Specialist (Quality Assurance Specialist)

Abbott has maintained a strong presence in Ireland since 1946 and celebrates its 80th anniversary in the country in 2026. The company supports the Irish healthcare sector with a broad portfolio spanning diagnostics, diabetes care, medical devices and nutritional products. Today, Abbott employs more than 6,500 people across ten sites located in Dublin, Donegal, Clonmel, Cootehill, Galway, Kilkenny, Longford and Sligo.

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 122,000 colleagues serve people in more than 160 countries.

The PQA Specialist is responsible for ensuring that product complaints, customer communications, risk evaluations, and related quality activities are managed and completed in compliance with Abbott's Quality Management System, applicable international standards (e.g., ISO 13485), regulatory requirements, and relevant medical device regulations.

·        Support the effective management, investigation, and timely closure of product complaints.

·        Track and monitor the status of all product complaints and external customer communications.

·        Perform complaint trending and analysis to identify recurring issues and emerging risks.

·        Prepare and maintain complaint documentation associated with distributed product investigations.

·        Follow up on complaint investigations and customer communications through to closure.

·        Author and review customer communications and Quality Technical Communications as required.

·        Identify and escalate potential product quality risks to Quality Management.

·        Support distributed product investigations, non-conformance investigations, and CAPA activities as required.

·        Ensure quality records are maintained in accordance with site, divisional, and regulatory requirements.

·        Demonstrate a strong understanding of the Quality Policy and apply it consistently in day-to-day activities.

·        Promptly report quality system non-compliance issues to management.

·        Compile, analyse, and report complaint and investigation data in a timely manner.

·        Monitor complaint trends and provide recommendations for continuous improvement.

·        Support risk assessments associated with post-market surveillance activities.

·        Support internal, external, customer, and regulatory audits as required.

·        Ensure compliance with applicable regulatory and quality standards, including ISO 13485 and relevant medical device regulations.

·        Conduct all activities in a manner that protects human health, safety, and the environment.

·        Comply with all applicable EHS legislation, Abbott Global Standards, and Technical Standards.

·        Timely closure of complaint investigations and customer communications.

·        Accurate administration and maintenance of quality records.

·        Timely preparation of analysis, trending reports, and investigation documentation.

·        Ensuring compliance with site and divisional quality requirements.

The following qualifications provide the necessary foundation for success in this role:

·        Bachelor's degree in Natural Sciences, Biotechnology, Quality Engineering, Life Sciences, or a related discipline.  Alternatively, a relevant postgraduate qualification combined with appropriate industry experience.

·        Minimum of 1-2 years' experience within the Medical Device, Biotechnology, Pharmaceutical, or regulated manufacturing industry is preferred.

·        Experience supporting complaint handling, post-market surveillance, CAPA, or quality systems activities.

·        Familiarity with ISO 13485, FDA Quality System Regulations, MDR/IVDR, or similar regulatory frameworks.

·        Experience of participating in internal or external audits.

·        Strong problem-solving and analytical skills.

·        Excellent written and verbal communication skills.

·        Ability to work effectively with internal and external stakeholders at all organisational levels.

·        Strong attention to detail and commitment to accurate record keeping.

·        Ability to manage multiple priorities while meeting deadlines.

·        Working knowledge of quality systems and regulatory requirements within a regulated environment.

·        Individual Contributor role.

·        Works independently with guidance from Quality Management as required.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:  Abbott in Ireland | Benefits

Connect with us at www.abbott.com and on LinkedIn, Facebook, Instagram, X and YouTube.

In specific locations, the pay range may vary from the range posted.