• Anywhere

R.T. Lane Recruitment

Are you a Senior Quality Engineer with at least 5 years experience and strong Validation and Projects experience gained within Manufacturing?

This is a permanent opportunity with an expanding multinational – great opportunity for flexibility, can be based in Shannon or Galway.

Contact Rachel for more details 087 9669394 or rachel@rtlanerecruitment.ie or apply here and we will respond asap

Role:

  • Developing and implementing solutions to sustain and improve the Quality Management System
  • Working cross-functionally to develop and lead quality systems strategies and objectives
  • Supporting various operational /manufacturing groups and suppliers to achieve the site’s strategic plan.
  • Performing quality engineering analysis to identify strategies to prevent quality non-conformances and minimize risk.
  • Working with suppliers, manufacturing, engineering, and other functional areas to assist and verify the implementation and effectiveness of the corrective/preventive actions taken for non-conformance
  • Developing validation strategies and support the successful execution of same
  • Supporting and representing the site during external regulatory audits.
  • This is not an exhaustive list of duties or functions and may not necessarily comprise all of the “essential functions” for purposes of the ADA.

Expected Areas of Competence (i.e. KSAs)

  • Familiar with all aspects and elements of a compliant quality system
  • Knowledge on aspects of quality assurance techniques such as: inspection methods, statistical sampling plans, validation, and statistical process control.
  • Demonstrated technical expertise, preferably in End of Line operations such as Packaging and Cleaning and operating in a controlled environment.
  • Able to work independently or as part of a team and consider options for completing work
  • Strong written and verbal communication skills

Education/Experience Requirements

  • Bachelor’s Degree in Quality or Engineering field, or an equivalent combination of education and experience.
  • Must have minimum of 5 years of experience in Quality Engineering field
  • Experience of working in a regulated industry, preferably medical devices

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