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Search Results for Quality Systems Engineer
Job Title. Location Salary Actions

Associate Director Quality Risk Management System

Associate Director Quality Risk Management System Our client, a leading biotech organisation are currently recruiting for an Associate Director Quality Risk Management System. As Associate Director Quality Risk Management System you will be global process owner of the end to end Global Quality Risk Management System across global functions at sites, including combination product development, Drug substance and drug product clinical and commercial production. You will be responsible for ensuring adoption of Risk Management principals is applied across disciplines and lifecycle throu...

Location: Limerick,
Associate Director Quality Risk Management System
Limerick Not Disclosed

Quality Systems Engineer Career Profile

Quality Systems Engineer


A Quality System is responsible for the design, implantation and maintenance of Quality Systems in a medical device company.

Role/Responsibilities

  • Quality System compliance to ISO9001, ISO13485 and Medical Devices Directive
  • Represent EMEA on global quality initiatives
  • Liaise with EMEA manufacturing sites and subcontractors
  • Drive and implement Quality System Improvements Perform audits of subcontractors
  • Perform internal audits
  • Support external audits
  • Manage CAPA and Event Investigations for site

Skills/Experience

  • Engineer/Science qualification with minimum of 8 years working within QA/RA in a multi-national Medical Devices environment
  • Attention to detail and accuracy - essential
  • Ability to work well under deadlines and pressure
  • Problem solving skills for developing creative solutions and meeting objectives are required
  • Skills that enable coordination of data, including MS-Office (primarily PowerPoint, Word, MD Project, Outlook and Excel)
  • Excellent analytical ability
  • Communication skills
  • The ability to prioritize tasks and be able to manage several projects and tasks simultaneously; and the ability to interface with all levels of management.