Quality Document Controller - Medical Devices (12 Month)

Abbott; Galway; On-site; EUR 42,000 - 54,000; Full time

Job summary

Abbott Ireland in Galway is seeking a Document Controller to support the Quality Team and ensure adherence to ISO 13485 and IVDR within Abbott Rapid Diagnostics Galway. The role centers on documenting control within the QMS and lifecycle management of documents.

You will maintain records, support audits, and collaborate across teams to implement quality documents. A Bachelor’s degree and at least 1 year of related experience are required, with fluent English and strong organizational skills.

Qualifications

• 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.
• 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.
• Fluent in English, with strong verbal and written communication skills.

Responsibilities

• Carries out duties in compliance with established policies and procedures.
• Demonstrates commitment to development, implementation, and effectiveness of quality processes per ISO, IVDR and regulatory agencies.
• Responsible for maintaining the QMS documentation program and control of records.
• Responsible for preparation, issuing, maintaining and control of documentation throughout its life cycle.
• Review and coordinate to ensure all submitted documents meet QMS standards and requirements; approve changes.
• Arrange documents to take effect and inform involved personnel to ensure changes are implemented timely.
• Standardize the writing of document records and advise on format, style, and architecture of documents.
• Assist in drafting, approval and distribution of other quality system documents and promote consistency of quality management.
• Participate in internal and external audits; support IVDR programme and ARDG as required.
• Perform other duties and projects as assigned.

Skills

Quality documentation

Regulatory compliance

Attention to detail

Project management support

Interpersonal skills

Education

Bachelor’s degree in Life Science or Engineering

Tools

MS Word

Excel

Outlook

PowerPoint

Agile

Job description

Abbott Ireland in Galway is seeking a Document Controller to support the Quality Team and ensure adherence to ISO 13485 and IVDR within Abbott Rapid Diagnostics Galway. The role centers on documenting control within the QMS and lifecycle management of documents.

You will maintain records, support audits, and collaborate across teams to implement quality documents. A Bachelor’s degree and at least 1 year of related experience are required, with fluent English and strong organizational skills.