Document Control Specialist

The primary function of this role is to ensure regulatory adherence of Cook Medicals document control process.

Find out more about Cook Medical here

Responsibilities

• Change Analyst within the Agile Product Lifecycle Management (PLM) system.
• Processing and GMP / GDP review of Change Orders (CO’s).
• Ensure Change Orders are implemented fully.
• Maintenance, control and distribution of Quality System documentation.
• Obsolete and distribute Quality Management System documents.
• Maintenance and control of the Document log.
• Generation and distribution of data on the effectiveness of the Documentation system.
• Global Part Number (GPN) Assignment and CIMS update for non Cook Ireland product.
• Bill of Material (BOM) updates.
• Supply Chain updates for non Cook Ireland product.
• Global Product File (GPF) updates and maintenance of the GPF.
• IFU/PFI File Management updates.
• Implementation of Global Document Control processes and systems as appropriate.
• Management and maintenance of Quality Systems records.
• Participation in Internal Audits if desired.
• Support External Audits where required.
• Provide training on Quality System procedures where required.
• Ability to lead and drive assigned Process Improvements within the Document Control Department essential.
• Ensure that Cook’s Code of Conduct is considered in all business matters carried out on Cook’s behalf.

Qualifications

• Cert/Diploma in Quality related discipline desirable.
• Excellent PC skills, particularly Microsoft Office.
• Previous experience of working in a Quality environment would be advantageous.
• A self starter and motivated to learn all aspects of the role.
• Ability to work independently but also work well as part of a team.
• High attention to detail.
• Strong interpersonal skills with the ability to communicate effectively at all organisational levels.
• Project Management abilities highly desirable.
• Strong organizational skills. Ability to set priorities, develop a work schedule, monitor progress towards goals, and track details/data/information/activities.
• Willingness and availability to travel on company business.
• Qualified and experienced Quality Auditor desirable but not essential.