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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.