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Quality Assurance Engineer (Operations)

On-site
  • Leitrim, Connaught, Ireland
Quality Assurance

Job description

Our client, a leading medical device company in Leitrim is looking for a Quality Assurance Engineer to join their team.


Job Responsibilities include but are not limited to the following:

  • 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 Programme and Internal Quality Audit Programme.
  • Co-ordination & maintenance of the Calibration and 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.
  • Adhere to Plant Safety requirements and Health & Safety requirements relating to your work, assuming responsibility for those aspects of the OH&S System over which you have control to ensure the health and safety of yourself and others.
  • Be aware of the potential environmental impacts associated with your work and the implications of non-conformance.
  • Contribute to enhanced energy performance by conservation of energy where possible (Lighting, Equipment, Air Conditioning etc) and  to the continual improvement activities of the OH&S, Environmental and Energy Management systems through participation,
  • Providing feedback/ suggestions for improvement and by reporting accidents, dangerous occurrence, near miss/ illness, good catch and environmental incidents in a timely manner.

Job requirements

  • Third level qualification in Engineering/Manufacturing/Quality with emphasis on Medical Device/Biomedical
  • 2-3 years’ experience as Quality/Validation Engineer in Medical Device/Pharmaceutical Environment
  • A Senior position may exist for a minimum of 6 years experience
  • Fully PC literate, use/knowledge of Minitab would be beneficial


Note: By applying for this position, you may also be considered by Pale Blue Dot® Recruitment for other or future related vacancies.


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