Job Description
Role: Validation Engineer Location: Carrick on Shannon, Leitrim Benefits: Competitive salary, Bonus, pension, healthcare and hybrid working Company: Work with theLargest employer in Leitrim show specialise in making Catheters all inhouse. Work in a company have cleanrooms dedicated to customers, very specialised. Generally have about 100 promotions per year Projects involved, individual plans, goal setting, leadership training. Responsibilities Ensuring that product introductions & change controls are effectively managed in accordance with the requirements of ISO 13485. 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 Completion of Validation Programme Risk Analysis, VMP,IQs, OQs, PQs as required according to procedure QAP 030 and other related procedures 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. Qualifications Required: Third level qualification in Engineering / Manufacturing / Quality with emphasis on Medical Device / Biomedical. Minimum Bachelors degree in a Science / Engineering / Quality related discipline. 1+ years experience in a Quality role in Medical Device/Pharmaceutical Environment An Associate position may exist where there is limited experience and will be assigned to an experienced Engineer. Does this sound like your next career move? For more info forward your application or contact me on OR Skills: Validation Manufacturing Quality Benefits: Bonus, pension, healthcare and hybrid working