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Job Description
**Medical Device QA Engineer Needed**
A leading medical device company in Leitrim seeks a QA (Validation) Engineer for a 6-month contract to join their expanding team.
Below are the key responsibilities and requirements for the position:
• Ensure product introductions and change controls are managed effectively in accordance with ISO 13485, MDD 93/42/EEC & MDR 2017/745 requirements.
• Participate in new product introductions programs to ensure effective introduction in accordance with ISO 13485 requirements.
• Generate Product Technical Files and associated studies in accordance with MDD 93/42/EEC & MDR 2017/745 when appropriate.
• Complete Validation Program – Risk Analysis, VMP, IQ's, OQ's, PQ's as required according to procedure QAP 030 and other related procedures.
• Manage QA/Technical/Associate/Engineers (Validation) as applicable.
• Review and release of batch paperwork for product release.
• Adhere to Plant Safety requirements and Health & Safety requirements relating to your work.
• Be aware of potential environmental impacts associated with your work and implications of non-conformance.
• Contribute to enhanced energy performance by conservation of energy where possible.
• 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.
**Requirements:**
• 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.
• Associate position may exist where there is limited experience.
• Senior position may exist for a minimum of 6 years' experience.
• Minitab experience is highly desirable.