QA/QC Technician

Job Overview


Quality Lab Technician required for a Medical Device company in Galway

The main purpose of the Quality Technician job is to focus on Analysis and Investigation of medical devices returned from the field for which there is a complaint allegation.

Duties
Login and decontamination of complaints devices returned from the field per departmental standards and procedures.

Analysis of the returned medical devices
Support root cause investigation of complaint events based on details reported from the field.
Responsible for entering all results related to analysis and investigation into the complaint handling database.
Support complaint evaluation activities in conjunction with department team members as required.
Tracking and Archiving of all returned products per regulatory requirements.
Review of the manufacturing documentation for complaint devices and inputting the Lot History review into the complaint database.
Ensure timely completion of assigned activities to meet Customer needs, departmental goals and regulatory reporting requirements.
You will contribute to continuous improvement activities


Requirements

· Level 6 NFQ or above in Engineering/Science or related discipline
· 1-2 years relevant experience in a medical devices or related environment.
· Experience/understanding of complaint handling or CAPA processes are desirable.
· You must be able to think critically and make sound decisions.
· You must be focused on patient safety and customer service, set high standards, instils operational excellence, drive accountability and model ethical behaviour.
· Good communication skills and fluent English, both in writing and speaking.

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