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.
Reporting to: Manager, Labeling Assurance
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Responsibilities:
- General project management: Supervise projects through the development process, liaise with stakeholders, communicate progress, prioritise tasks, and help to resolve issues or take corrective action as required.
- Change control: 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).
- Process improvement projects: Develop new processes where required and optimise current processes within the Cook Medical quality system requirements.
- Layout/design: 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.
- File transfer and management while maintaining strict version control: 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 .
- Other responsibilities as assigned.
- Ensure that Cook’s Code of Conduct is considered in all business matters carried out on Cook’s behalf.
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Qualifications:
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- Bachelor’s degreeis 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.
- Willingness and availability to travel on company business.