Engineer 2 – Labelling Assurance

Role Overview

• Designs, proofreads, and coordinates the development and implementation of controlled documents applicable to Cook Ireland Labeling Assurance, specifically instructions for use manuals, product labels, patient/implant cards, digital patient-facing information, and instruction leaflets.
• Works closely with Product Management, Engineering, and Regulatory Affairs, as well as representatives from other departments and outside vendors, to ensure smooth development and timely execution of projects.
• Supervise projects through the development process, liaise with stakeholders, communicate progress, prioritise tasks, and help to resolve issues or take corrective action as required.
• Write change orders to create new and/or update existing labelling assets using the electronic change control system. Manage those changes through the various approval stages to final implementation.
• Participate as an SME (subject matter expert) in projects requiring input from a Labeling Assurance perspective.
• Meet all timelines and relevant actions of assigned CAPAs/NCRs and present progress at CAPA assignee meeting and CRB (CAPA Review Board).
• Develop new processes where required and optimise current processes within the Cook Medical quality system requirements.
• Work in InDesign software to typeset IFUs, patient-facing information (PFIs), and patient cards that conform to predetermined sizes and standards; work in the company labelling system to design, update, and approve product labels and implant cards.
• Proofread various documents against their source files to ensure accuracy.
• Manage document files as they move through the process of review, approval, translation, printing, and implementation.
• Liaise with outside vendors (e.g., translation and printing companies), providing them with source files, clarifying any issues or questions, and ensuring their timelines adhere to project schedules.
• Maintenance of data within the company labelling system, including administration of user access and permissions for relevant personnel and monthly archiving of product information.

Requirements

• Bachelor’s degree is desired, preferably in engineering/science or a related field and / or relevant experience.
• Minimum of 3 years’ relevant experience.
• Previous experience of working within a quality system is preferred.
• Excellent project management skills is advantageous.
• Proficiency or ability to quickly learn multiple software packages and use them interchangeably on a daily basis.
• Excellent knowledge of the English language with regard to spelling, syntax, and grammar.
• Highly developed file-management and organisational skills.
• Excellent attention to detail.
• Ability to efficiently multitask.
• Ability to deal with frequent changes of priority and multiple project revisions.
• Ability to work remotely and communicate effectively via electronic and other methods.
• Comfort with and ability to meet tight deadlines.
• Excellent communication and interpersonal skills.
• Self-motivated, problem-solving team player.

Benefits

• Professional development opportunities
• Willingness and availability to travel on company business