Document Controller - IVDR

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 6,200 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 Rapid Diagnostics is part of Abbott's 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 significate growth for Abbott in COVID 19 related products in over 70+ countries.

Position Summary

The Quality Assurance Document Controller is a member of the Quality Team and plays an important role in supporting the business in adhering to its quality and regulatory objectives. Additionally, this role is focused on Document Control activities for Abbott Rapid Diagnostics Galway (ARDG) QMS. The role is fundamental to supporting the implementation & maintenance of Abbott's Quality System in alignment with applicable regulations and standards including EN ISO 13485:2016/A11:2021 and EU Regulation 2017/746 (IVDR) as well as other applicable standards and regulations. This is an exciting opportunity to join our team as a Document Controller on a 12 month fixed term contract, and this role will involve the following Essential Duties and Responsibilities (Key Activities).

Essential Duties and 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, IVDR 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 compliance consequences which may occur from the improper performance of specific duties.
• Responsible for maintaining the QMS documentation program and also responsible for the control and distribution of records and overseeing the implementation of quality documents.
• Responsible for preparing, issuing, maintaining, revisioning, filling and control of documentation throughout its whole life cycle.
• Review and coordinate to ensure that all submitted documents meet the standards and requirements of the QMS.
• Approve administrative changes to controlled documents for Quality Assurance Team.
• Arranging documents to take effect and inform involved personnel to ensure all document changes are implemented in a timely manner.
• Standardize the writing of document records and the requirement for review and approval.
• Provides guidance on format, style, and architecture of documents to enhance standardization and clarity and to minimize unnecessary updates.
• Assist in the drafting, approval and distribution of other quality system documents and promote the consistency of quality management.
• Participate and support internal and external audits.
• Responsible for tasks associated with the IVDR programme and ARDG as required.
• Perform other duties and projects as assigned.

Education / Experience / Skills

• Bachelor's degree in Life Science, Engineering, or closely related discipline is required OR relevant combination of education or experience.
• A minimum of 1 year experience required.
• Previous experience as a Document Controller for Quality would be a distinct advantage.
• Experience working in Medical Devices or similar regulatory environment preferred.
• Excellent attention to detail and ability to work well to tight deadlines.
• Experience in Quality Management Systems preferred.
• Strong interpersonal, written and administrative skills, including experience with project management support.
• Pro active attitude, excellent organization skills, and ability to manage multiple projects while delivering results on time.
• Proven ability to work alone and in a team environment.
• Proficient with MS Word, Excel, Outlook, Power Point, and management of spreadsheets.
• Experience in using an electronic document management system (e.g., Agile).
• Fluent in English, with strong verbal and written communication skills.

Job Details

• JOB FAMILY: Operations Quality
• DIVISION: ID Infectious Disease
• LOCATION: Ireland > Galway : Parkmore East Business Park
• ADDITIONAL LOCATIONS:
• WORK SHIFT: Ie - 37.5Hst0 (Ireland)
• TRAVEL: No
• MEDICAL SURVEILLANCE: No
• SIGNIFICANT WORK ACTIVITIES: Not Applicable

Additional Information

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The base pay for this position is N/A In specific locations, the pay range may vary from the range posted.

Why Abbott

Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential - because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions - across the spectrum of health, around the world, for all stages of life. Whether it's next generation diagnostics, life changing devices, science based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.

Equal Opportunity

An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.

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