Our client, a leading medical device company based in Leitrim are seeking a QA (Validation) Engineer for a 6 month contract to join their expanding team.
Responsibilities include but are not limited to : 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.
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.
Degree in Engineering/Manufacturing/Quality with emphasis on Medical Devices/Biomedical.
Ideally 2-3 years previous experience as Quality/Validation Engineer in Medical Device/Pharma Environment.
An Associate position may exist where there is limited experience.
A Senior position may exist for a minimum of 6 years' experience Minitab experience is highly desirable Note: By applying for this position, you may also be considered by Pale Blue Dot Recruitment for other or future related vacancies Pale Blue Dot Recruitment - The Resource for the MedTech Workforce
