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Collins McNicholas

Quality Engineer

Job Summary:

Reporting to Quality Manager.

Duties & Responsibilities include but are not limited to:

  • 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

Education & Experience Required:

  • Degree in Quality or Degree in Science / Engineering.
  • 5+yrs industry 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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