Telephone: 086 8395533
Associate Quality Engineer
Our client, a medical device company in Galway are currently looking to recruit an Associate Quality Engineer for their site on a fixed term contract.
Duties and Responsibilities
- Possesses and applies a fundamental and increasing knowledge of Quality, and its application within the company, 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 company 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.
For further information on this Associate Quality Engineer role in Galway please contact Bimi Felix on 086 8395533 / firstname.lastname@example.org
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