Associate Quality Engineer Galway
£36144 - £37048
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This is an 18month fixed-term-contract and is a fantastic opportunity for someone starting out in their career in quality who wants to grow and develop their skills with a reputable and successful company and an extremely talented and experienced team.Responsibilities and Duties
* Possesses and applies a fundamental and increasing knowledge of Quality, and its application within RDIL, to the completion of routine assignments.
* Works in compliance with established procedures and/or protocols. Identifies and resolves readily identifiable, clearly-defined problems. Demonstrates skill in data analysis techniques by resolving missing/incomplete information in routine assignments.
* Administration and Organization of documentation relating to preparation and implementation of MDR/IVDR including recognizing where escalation points are required.
* Compliant distribution - QA approval of Product supporting the interface between commercial organizations/ distribution business and Legal Manufacturers.
* Compliant warehousing and handling - QA approval of Product disposition supporting the interface between Warehouse Inventory Control and Legal Manufacturers
* Continuous improvement - Administration and support of the CAPA/ NC process through weekly continuous improvement meetings.
* Escalation point for quality related non-conformances and CAPAs.
* Execution of product recalls and customer notifications supporting the interface between commercial organisations and Legal Manufacturers.
* Cross-functional Team member - represents QA in cross-functional teams where business needs require.
* Support QA structure for AIL Galway activities. Requirements
* Minimum 1 years' experience in medical device industry, including;
* Competent working knowledge of recognized Quality Management Systems (e.g. ISO9001/ ISO13485/ ISO14971/ GMP),
* Working knowledge of the requirements relevant to the implementation of MDR/IVDR regulations
* Understanding of other relevant regulations relating to medical device eg FDA, WHO etc
* Competency in conducting technical review of all documentation/ communications.
* Broad knowledge of engineering and technical applications applied in development of medical devices useful. 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