Role: QA Engineer (Validation)
Location: Carrick on Shannon, Leitrim
Benefits: Competitive salary, Bonus, pension and healthcare
Company:
Work with the Largest employer in Leitrim specializing in making Catheters in-house. The company has cleanrooms dedicated to customers, very specialized. Generally, there are 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 programs 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 Program – Risk Analysis, VMP, IQ’s, OQ’s, PQ’s 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 occurrences, near misses/illness, good catches, and environmental incidents in a timely manner.
Qualifications:
Third level qualification in science/biomedical/engineering desirable.
2+ years in a similar role within the Medical Device industry.
If this sounds like your next career move, forward your application or contact me on 087 0612325 or [email protected]
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