Quality Engineer - AJ Precision Components Ltd

Company profile: 

AJ Plastic Components is a leading sub-contract manufacturer of precision injection moulded components and assemblies to leading companies in the medical device, pharmaceutical and automotive sectors. We specialise in manufacture & validation, packaging & assembly of precision moulding products. Established in 1980, our 66,000 sq/ft facilities are strategically located in one of the most successful medical device clusters in Europe. In 2017, AJ Plastic Components was acquired by Synecco. Based in Galway, Ireland, Synecco are a leading Design & Contract Manufacturing provider to the medical device industry

Description of role: 

  • Provide day to day quality support to the manufacturing and engineering teams. 
  • Manage CAPA, NC’s and Customer Complaints.
  • Ensure that preventive and corrective actions are taken in relation to product and Quality system deficiencies and initiate, recommend or provide solutions to product and Quality system related problems
  • Participate in Root Cause Analysis. 
  • Provide reports/information to management on quality related issues and implement solutions to quality related issues
  • Participate in internal/external audits as required
  • Carry out metrology activities, relating to drawings, measurements, geometrical dimensions and tolerances
  • Interface with other departments to ensure that Quality system requirements are adhered to
  • Follow all environmental, health & safety rules and procedures and participate in safety and environmental activities in order to improve the workplace for all employees

Skills and knowledge requirements:

  • Degree in Quality or Degree in Science / Engineering. 
  • Experience in a Medical Device-manufacturing or Pharmaceutical environment. 
  • Working knowledge of FDA/ISO Quality systems for Medical Device companies.
  • New product introduction and manufacturing process transfer experience would be a distinct advantage.
  • Good working knowledge of Quality System Requirements within the Medical Device Industry – ISO13485:2016 & FDA
  • Quality auditor experience/certification
  • Good communication skills - written and oral communication skills essential

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