Associate Quality Engineer

Our Client a  major multinational based here in  Galway are looking for an  Associate Quality Engineer for an exciting new project on a 6 month fixed-term contract.

The Associate Quality Engineer provides a support role to the Quality Manager in the routine maintenance of Quality and other business Management Systems.

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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.

Requirements

• 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.

For more information and a confidential discussion on the role please contact  Michelle Mc Inerney.

[email protected]

091 706717