Our client a medical device company in Galway is looking to hire a Laboratory Technician - Returned Product Analysis on a 12-month basis.
At our Product Experience Management (PXM) group, which is part of the Galway PXM Complaint Handling and Regulatory Reporting Department, we focus on complaint handling and post market regulatory reporting activities for a wide range of products. You will be part of a high performing Complaint Handling and Medical Device Regulatory reporting department, which provides value throughout the Product Life cycle through world class execution in Medical Device Reporting and Vigilance compliance.
- Performs a variety of duties in the electronic, mechanical, electromechanical, and/or optical areas.
- Constructs, troubleshoots, calibrates, adjusts, tests, diagnoses, and maintains equipment, components, devices, or systems.
- Works from schematics, engineering drawings and written or verbal instructions.
- Operates related equipment; conducts test and reports data in prescribed format.
- Performs calibration and alignment checks; makes adjustments, modifications, and replacements as directed; prepares prescribed compounds and solutions.
- Performs co-ordination and data entry activities for product returned for analysis as part of the Complaint Handling Process including product receipt, traceability and archiving of all devices received as per regulatory requirements.
- Perform daily monitoring of chemicals and maintenance of chemical solutions for the decontamination process. Perform initial analysis and decontamination of returned devices.
- Perform product analysis and investigations including review of manufacturing documentation and the documentation of investigation results for complaint files as appropriate. And lead or support root cause investigations; drive problem solving efforts to support complaint file completion.
- Ensure timely completion of assigned activities to meet Customer needs, departmental goals and regulatory reporting requirements
- Lead or participate in COS and A3 activities in support of Cell Deployment activities in the PXM Department.
Key Skills & Experience
- Degree level (Level 7 NFQ minimum) in a relevant Engineering or Science discipline
- 1-2 years’ relevant experience in an operations or laboratory medical device or related environment.
- 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, instills operational excellence, drive accountability and model ethical behaviour.
- Candidates must be a good communicator and are fluent in English, both in writing and speaking.
For further information on this Clinical - Lab Technician role in Galway please contact Clara Burke on 086 8168273 / email@example.com
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