Quality Engineer | Collins McNicholas

Quality Engineer

  • Reference: GY43070
  • Job Type: Permanent
  • Location: Galway
  • Category: Engineering, Technical & Manufacturing

Duties and Responsibilities

  • Ensure that Production operations are completed in accordance with the requirements of the quality system and ISO13485:2003.
  • Ensure all customer requirements are identified, documented, understood and met.
  • Document manufacturing procedures, routes, purchasing specifications, inspection procedures and standards etc. Approve all updates to same.
  • Oversee the execution of validation activity as required.  Review and approve Master Validation Plans, FMEAs, IQ/OQ/PQ protocols and reports for product and process changes, new equipment and process improvement activities.
  • Drive improvement in product quality, as measured by reduced customer complaints and increased product yields.
  • Advise customers of proposed changes to processes / products / vendors etc. Overview the testing etc. required ensuring proposal has no effect on product.
  • Perform internal audits as per agreed schedule and prepare for external audits.
  • Review line issues and work with the team in implementing effective and timely resolutions. 
  • Ensure effective and timely resolution of Production related CAPA’s.
  • Review customer requests/complaints related to Production parts.  Ensure robust solutions are implemented.
  • Keep your skills current and be conversant with the latest developments in technologies and materials which are relevant to the Company’s business.
  • Participate in improvement activities, including Kaizen events, ensuring that quality requirements are followed during the change implementation process.
  • Function within a team environment and communicate information effectively to all stakeholders.
  • Keep your skills current and be conversant with the latest developments in technology and materials which are relevant to the Company’s business.
  • To take on other duties which the Company may assign you from time to time. These ‘other duties’ will be agreed with Management prior to any assignment.


  • Degree qualification in Engineering / BSc / Quality Systems OR significant relevant experience in a quality assurance role within the Medical Device Industry.
  • A minimum of 5+ years’ experience in a similar role in the Medical Device / Component Industry.
  • Excellent communication skills both verbal and written.
  • Excellent Administrative skills.
  • Ability to manage several tasks simultaneously.
  • Excellent attention to detail.
  • A positive attitude to dealing with people

For a confidential discussion and more information on the role/company please contact Amy O’Neill on 091-706718 or email amy.oneill@collinsmcnicholas.ie

For more information on our Recruitment and HR Services and to see a full list of our available jobs across Ireland, please visit our website www.collinsmcnicholas.ie

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Amy O’Neill

Contact Consultant

  • Amy O’Neill
  • Recruitment Consultant
  • 091706718
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