Overview

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.

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.