Would you like to work as a Quality Engineer in Ireland for a truly international organisation with 33,000 plus employees globally? Our client is one of the world’s leading medical technology companies and is dedicated to helping healthcare professionals perform their jobs more efficiently while enhancing patient care and quality. We are currently recruiting for a Quality Engineer. The client is looking for someone who has a Bachelor degree in Science, Engineering or equivalent/ related subject and 2 or more years of work experience in a quality discipline, or Masters of Science, Engineering or related subject with 1 year of quality engineering experience.
* Work closely with operations and the business functions to ensure quality performance of product and processes.
* Mentors provide oversight and approval of NC & CAPA, activist and high-level expert in problem-solving and root causing activities.
* Initiates and lead in the development and improvement of the manufacturing processes for existing and new products.
* Oversight and leads investigations during concession management.
* Review and approval of change management activities, challenges change effectiveness and drives strong review.
* Interpret KPI trends, take action as necessary, driving a continuous improvement process.
* An advocate of Human Factor practices, proficient in the science of Human Factor identification and mitigation.
* Proficiency in and provides technical direction in the optimization of inspection methods and sampling.
The European Medical Device Regulation (EU MDR) ensures high standards of quality and safety for medical devices being produced in or supplied into Europe. It has had a fundamental revision in 2017 to better identify medical devices products and improve transparency through standard data, technological advances and the establishment of an EU database (Eudamed). Similar to the FDA’s UDI, EU MDR will establish a robust, transparent, predictable and sustainable regulatory framework for medical devices to ensure a high level of health and safety whilst supporting innovation.
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