QA Engineer- Leitrim

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,

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