Associate Quality Engineer

Location: Galway City, Galway, Ireland
Date Posted: 02-07-2018
Position Summary
The Associate Quality Engineer provides a support role to the Quality Manager in the routine maintenance of Quality and other business Management Systems.    The Associate Quality Engineer reports to the QA & RA Manager.

Duties and Responsibilities
•    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 Galway activities.

Education & Experience
•    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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