Contact: Caroline Kingston
Telephone: 086 8395531
Clinical Lab Technician - Contract
Our client, a medical device company in Galway are currently looking to recruit a Lab Technician for their site on a contract basis.
(Returned Product Analysis) Lab Technician
At our Galway Product Return Analysis (RPA) Lab, which is part of the Product Experience Management (PXM) Complaint Handling and Regulatory Reporting Department, we focus on Analysis and Investigation of devices returned from the field for which there is a complaint allegation. Complaint Device Analysis and Investigation is performed within a high performing PXM Complaint Handling and Medical Device Regulatory reporting department which provides value throughout the Product Life cycle through world class execution in MDR and Vigilance compliance and by ensuring patient safety through thorough and timely processing of complaint devices.
- Login and decontamination of complaints devices returned from the field per departmental standards and procedures.
- Analysis of the returned devices as per departmental standards and procedures.
- 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 DHR section of 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 within the PXM department as required.
- We are looking for a qualified person with a Level 6 NFQ or above in Engineering/Science or related discipline and preferably with 1-2 years relevant experience in a medical devices or related environment.
- Candidates with a legal or clinical qualification (e.g. registered nurse or experience in physiological or clinical measurement science) will also be considered.
- We are looking for a dynamic team player who can work effectively and proactively on cross-functional teams. Experience/understanding of complaint handling or CAPA processes are desirable.
- Candidates must be able to think critically and make sound decisions. Candidates must be focused on patient safety and customer service, set high standards, instils operational excellence, drive accountability and model ethical behaviour.
- Candidates must be a good communicator and are fluent in English, both in writing and speaking
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