Cook Group

Engineer 2, Labelling Assurance – Contract

Cook Group

contract

Posted on:

Location Type: Office

Location: Limerick • Ireland

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About the role

  • 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.

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.
  • Willingness and availability to travel on company business.
Benefits
  • None specified 📊 Check your resume score for this job Improve your chances of getting an interview by checking your resume score before you apply. Check Resume Score
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
project managementchange controlprocess improvementtypesettingproofreadingfile managementversion controllabeling system administrationCAPA managementNCR management
Soft Skills
communicationinterpersonal skillsattention to detailmultitaskingproblem-solvingself-motivatedorganizational skillsability to meet deadlinesadaptabilityteam player
Certifications
Bachelor's degree in engineeringBachelor's degree in sciencerelevant experience in quality systems