Quality Engineer Dublin Medical Devices

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Role: Quality Engineer

Location: Dublin

Industry: Medical DevicesRole and responsibilities:

-Working as a part of a cross-functional team to design and develop a novel transcatheter heart repair device

-Demonstrating and promoting a commitment to improving patient safety, customer satisfaction and product quality.

-Support product verification and validation, including risk management, bio-compatibility testing (ISO 10993), microbiological (disinfection) validation and clinical evaluation

-Ensure quality in the product's design for durability, usability, reliability, functionality, marketability, and manufacturability

-Mitigating risks associated with the design, use and manufacture of Medical devices.

-Support implementation and maintenance of a robust and fully compliant quality system in accordance with ISO 13485, including risk management

-Continuous improvement of the QMS to meet the requirements of all stakeholders

-Preparation and maintenance of documentation in compliance with the appropriate regulatory requirementsRequirements:

-Degree in science, engineering, or related disciplines

-Minimum of three (3) years of related experience in medical device Quality or Design Assurance

-Class III medical product development experience preferred

-Working knowledge of FDA, GMP, QSR and ISO 13485 requirements.

-Experience of statistics and a good working knowledge of test method validation.

-Experience of preparing technical documentationFort immediate consideration APPLY TODAY with an up-to-date CV. To find out more about Real please visit www.realstaffing.comReal Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales