Senior Quality Systems Engineer Galway

Senior Quality Systems Engineer with experience of Quality system Management and development within a regulated environment. This role can be based in Galway or Shannon.

This is a permanent opportunity., Medical Devices experience is ideal for this manufacturing opportunity

  • Developing and implementing processes, procedures and instruction to sustain and improve the Quality Management System.
  • Supporting Top Management in the development and implementation of quality systems strategies and objectives.
  • Preparing the site to host external Regulatory and Corporate audits and demonstrating compliance.
  • Coaching and mentoring the organization in working within a medical device Quality Management System
  • Working with suppliers, manufacturing, engineering, and other functional areas to assist and verify the implementation and effectiveness of the corrective/preventive actions taken for nonconformance
  • Working within a cross-site team to implement best practices in methods and systems that drive Quality Excellence
  • Conducting audits and assessments of internal processes and suppliers manufacturing sites
  • Provide leadership and guidance within the Quality Systems team on best practice

Expected Areas of Competence (i.e. KSAs) 

  • Must be familiar with all aspects and elements of a quality system, in particular ISO13485 and FDA QSR.
  • Must have experience of hosting audits from external regulatory agencies and corporate functions.
  • Experience for leading cross-functional teams would be a benefit.
  • Demonstrates ownership for the integrity of work
  • Able to work independently and consider options for completing work
  • Strong written and verbal communication skills

Similar Posts

Leave a Reply

Your email address will not be published. Required fields are marked *