Validation Engineer - County Leitrim, Ireland - Cpl

Description

Validation Engineer

My Client, a large medical equipment manufacturer in the north-west of Ireland is looking to recruit a Validation Engineer.

Responsibilities:

• Ensuring that product introductions & change controls are effectively managed in accordance with the requirements of ISO 13485, MDD 93/42/EEC & MDR 2017/745.
• Participation in the new product introductions programmes to ensure that they are effectively introduced in accordance with the requirements of ISO Generation of Product Technical Files & associated studies in accordance with MDD 93/42/EEC & MDR 2017/745 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
• Management of QA/Technical/Associate/Engineers (Validation), as applicable) (Senior QA Engineer (Validation)
• Review and Release of batch paperwork for Product release
• 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).
• Contribute 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.

Required Qualifications/Experience/Skills:

• Degree in Engineering/Manufacturing/Quality with emphasis on Medical Devices/Biomedical.
• Ideally 4+ years previous experience as Quality/Validation Engineer in Medical Device/Pharma Environment.

For more information, please email

#LI-EG1