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 13845. 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 [email protected]
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