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The Associate Quality Engineer provides a support role to the Quality Manager in the routine maintenance of Quality and other business Management Systems.
Responsibilities and Duties
Possesses and applies a fundamental and increasing knowledge of Quality, and its application within Alere, 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 the QA Mailbox 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.
Minimum 1 years’ experience in medical device industry, including;
Competent working knowledge of recognized Quality Management Systems (e.g. ISO9001/ ISO13485/ ISO14971/ GMP),
Awareness of relevant laws and regulations (e.g. CE/ FDA/ PAL)
Competency in conducting technical review of all documentation/ communications.
Broad knowledge of engineering and technical applications applied in development of medical devices useful.
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ARDx Abbott Rapid Diagnostics
Ireland > Galway : Parkmore Business Park
Ie - 37.5Hst0 (Ireland)
SIGNIFICANT WORK ACTIVITIES: