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

Quality Systems Supervisor

Would you like to join a leading medical device company in Limerick, to further develop your career, and ensure the quality of medical devices for patients around the world? The primary function of this role is to supervise a team of Quality Systems Technicians within Document Control and a team of Quality Systems Engineers in the Quality Systems Engineering Function. You will report into the Quality Systems Manager Responsibilities Working closely with the Quality Systems Manager the responsibilities of the role are outlined below: • Supervising the Document Control an...

Location: Limerick,
Quality Systems Supervisor
Limerick Not Disclosed

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

Senior Quality Engineer

Senior Quality Engineer The Senior Design Assurance Engineer is accountable for quality support for products developed and process design to achieve these goals through active participation and contribution to multifunctional and multi-divisional teams. The Senior Design Assurance Engineer is responsible for assuring that quality standards and regulatory compliance activities are consistent with Corporate/Division Policies, Government Regulations, International Standards and standards broadly recognized by the Medical Device Industry. The position requires a self-motivated, self-d...

Location: Limerick,
Senior Quality Engineer
Limerick Not Disclosed
Other Quality Engineering Jobs
Job Title Location Salary Actions
Design Control Engineer 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.