QA Engineer- Leitrim | Collins McNicholas

QA Engineer- Leitrim

  • Reference: SJ43892
  • Job Type: Permanent
  • Location: Leitrim, Roscommon, Westmeath
  • Category: Engineering, Technical & Manufacturing

Our client, a leading Medical Device Company in Leitrim, is looking to hire a QA Engineer. 

Responsibilities:

  • Ensuring that product introductions & change controls are effectively managed in accordance with the requirements of ISO 13485 & MDD 93/42/EEC.
  • Participation in the new product introductions programmes to ensure that they are effectively introduced in accordance with the requirements of ISO 13845.  Generation of Product Technical Files & associated studies in accordance with MDD 93/42/EEC when appropriate.
  • Completion of Validation Programme – Risk Analysis, VMP,  IQ’s, OQ’s, PQ’s as required according to procedure QAP 030 and other related procedures
  • Integration & Maintenance of the Quality Management System with all processes in accordance with the requirements of ISO 13485 & MEDDEV 93/42/EEC.
  • 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 & MEDDEV 93/42/EEC.
  • 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 13845.  Generation of Product Technical Files & associated studies in accordance with MEDDEV 93/42/EEC when appropriate.
  • Maintenance of the Customer Complaint investigation process, MEDDEV  93/42/EEC vigilance requirements and 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
  • 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.
  • Vendor Assessment liaison & Maintenance.

Requirements:

  • Degree in Engineering/Manufacturing/Quality with emphasis on Medical Devices/Biomedical.
  • Ideally 2-3 yrs previous experience as Quality/Validation Engineer in Medical Device/Pharma Environment

For a confidential discussion, please contact Mark Whelan on 071 914 2411 or email mark.whelan@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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Mark Whelan

Contact Consultant

  • Mark Whelan
  • Senior Recruitment Consultant
  • 071 9140254
  • Connect with Mark

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