PQA Specialist (Quality Assurance Specialist)

Job description

JOB DESCRIPTION:Abbott in Ireland 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. About Abbott 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. Abbott Ireland Diagnostic Division – Longford: The Longford facility plays a key role in helping Abbott to meet the increasing global demand for diagnostic testing in areas such as infectious disease, cancer, thyroid, and cardiovascular diseases.  Longford is based in the midlands of Ireland surrounded by water with the River Shannon, Lough Ree and the Royal Canal. It has a vibrant collection of communities with a rich historical background. The County has plenty to offer to both visitors and citizens in sport, culture, literature, amenities, festivals, events, retail and dining. Please note any offer of employment for this position is conditional upon the successful completion of a pre-employment medical examination, including drug and alcohol screening, conducted by a medical practitioner designated by the Company. We have an exciting opportunity as a PQA Specialist and this role will involve the following Primary Function 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. Key Responsibilities Complaint Handling & Customer Communications ·        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. Quality Systems & Compliance ·        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. Data Analysis & Reporting ·        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. Audit & Regulatory Support ·        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. Environmental, Health & Safety (EHS) ·        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. Accountability ·        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. Education & Experience 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. Key Skills ·        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. Reporting Structure ·        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. The base pay for this position is N/AIn specific locations, the pay range may vary from the range posted. JOB FAMILY:Operations Quality DIVISION:CRLB Core Lab LOCATION:Ireland > Longford : Lisnamuck ADDITIONAL LOCATIONS: WORK SHIFT:Ie - Lfdflsg2 (Ireland) TRAVEL:No MEDICAL SURVEILLANCE:Yes SIGNIFICANT WORK ACTIVITIES:Not Applicable