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Quality Engineer NPI

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Mark Wilson
+353 86 0449473
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Recruitment Consultant

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Quality Engineer NPI

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Senior Quality Engineer NPI (Hybrid)

We have an exciting opportunity available for a Quality Engineer II or a Senior to join our Client in County Leitrim. This is an exciting opportunity to work with an established medical device manufacturing company and work in their Product development team.

Key Responsibilities

  • Integration & Maintenance of the Quality Management System with all  processes in accordance with the requirements of ISO 13485, MDD 93/42/EEC & MDR 2017/745.
  • Deputising for the Management Representative in their absence.
  • Provision of support to all departments to ensure that products manufactured meet customer requirements
  • Ensuring that product introductions & change controls are effectively managed in accordance with the requirements of ISO 13485, MDD 93/42/EEC & MDR 2017/745.
  • Review and Release of batch paperwork for Product release
  • Participation in the new product introductions programmes to ensure that they are effectively introduced in accordance with the requirements of ISO 13485. Generation of Product Technical Files & associated studies in accordance with MDD 93/42/EEC & MDR 2017/745 when appropriate.
  • Maintenance of the Customer Complaint investigation process, MDD 93/42/EEC & MDR 2017/745 vigilance requirements assisting in product recalls & corrective/ preventive action programme
  • Participation in routine Failure Investigation & process trouble-shooting
  • Maintenance of plant Trending & Continuous process improvement programmes
  • Participation in the Plant Corrective Action Programm
  • Participation in the Internal Quality Audit Programme
  • Co-ordination & maintenance of the Calibration Programme
  • Co-ordination & maintenance of the Validation Programme
  • Maintenance of the Plant Environmental & Cleaning/ Housekeeping Programme, including sub-contractor maintenance
  • Maintenance of the Plant Laundry & Rodent Control Sub-Contractors to required standards
  • Vendor Assessment liaison & Maintenance
  • Ensuring that quality system & product requirements are included in the plant Training Programmes designated trainer


  • Required: Third level qualification in Engineering / Manufacturing / Quality with emphasis on Medical Device / Biomedical. Minimum Bachelor’s degree in a Science / Engineering / Quality related discipline.
  • 2-3 years’ experience as Quality/Validation Engineer in Medical Device/Pharmaceutical Environment
  • An Associate position may exist where there is limited experience and will be assigned to an experienced Engineer.
  • A Senior position may exist for a minimum of 6 years` experience
  • Fully PC literate, use/knowledge of Minitab would be beneficial

For further information on this role in please contact Mark Wilson on 0860449473 or email

Check out all our open jobs on our HERO Recruitment website –

Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.

Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given. You have supplied us with your personal data in the process of applying for a position. Our client company may have personnel outside of the EEA who will review you data. We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.



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