Regulatory Document Control Lead – Quality Systems

Cook Medical Incorporated; Limerick; On-site; EUR 35,000 - 55,000; Full time

Job summary

Cook Medical Incorporated in Ireland is seeking a Change Analyst focused on regulatory adherence of the document control process within the QA/QMS framework. The role covers GMP/GDP review of change orders, maintenance of the document log, and distribution of quality system documents.

The position includes updating global product files, BOMs, and GPFs for non-Ireland products, plus supporting internal and external audits and training on procedures.

Qualifications

• Cert/Diploma in Quality-related discipline desirable.
• Excellent PC skills, particularly Microsoft Office.
• Previous experience in a Quality environment would be advantageous.
• Self-starter with motivation to learn all aspects of the role.
• Ability to work independently and as part of a team.
• Strong organizational and communication skills.

Responsibilities

• Change Analyst within PLM system.
• Processing and GMP/GDP review of Change Orders.
• Ensure Change Orders are implemented fully.
• Maintain, control and distribute Quality System documentation.
• Obsolete and distribute Quality Management System documents.
• Maintain and control the Document log.
• Generate and distribute data on document system effectiveness.
• GPF updates and maintenance for non-Ireland product.
• BOM updates and supply chain updates for non-Ireland product.
• IFU/PFI File Management updates.
• Implement Global Document Control processes and systems.
• Maintain Quality Systems records.
• Participate in Internal Audits and support External Audits as needed.
• Provide training on Quality System procedures.
• Lead and drive assigned Process Improvements in Document Control.
• Ensure Cook’s Code of Conduct is followed.

Skills

Attention to detail

Interpersonal communication

Independent work

Team collaboration

Project management (desirable)

Organizational skills

Travel willingness

Strong IT skills

Education

Quality-related Cert/ Diploma (desirable)

Tools

Microsoft Office

Job description

Cook Medical Incorporated in Ireland is seeking a Change Analyst focused on regulatory adherence of the document control process within the QA/QMS framework. The role covers GMP/GDP review of change orders, maintenance of the document log, and distribution of quality system documents.

The position includes updating global product files, BOMs, and GPFs for non-Ireland products, plus supporting internal and external audits and training on procedures.