Quality Technician - Manufacturing (Evening Shift)
Work closely with the Quality Engineering Team and provide front line quality support to ensure all manufacturing process, materials and products are supported from a quality and compliance perspective. Lead improvement activities within these areas to ensure all systems and processes are efficient and effective. Other activities may be assigned as needed.
During periods of absence, the Quality Engineer shall ensure that all the responsibilities of this position are appropriately assigned. The Quality Engineer has the authority to act on behalf of the Quality Technician.
The position requires the person to take the lead in the following areas of Quality:
•Support of Manufacturing process changes and improvements including Quality Inspection at different points in the process.
•Material Review Board (MRB) system and material control Incoming Inspection System and process.
•NC/CAPA ownership and closure.
•Process Quality Control to ensure all product meets its requirements prior to shipment.
•Corrective Action activities related to manufacturing process and systems.
•Identifying any potential trends during failure analysis and initiating improvement initiatives
•Trending and reporting on the Key Quality and Performance Objectives for manufacturing quality
•Maintain compliance with ISO and FDA Quality System regulations
The role will also support external audits, internal audits and any relevant Quality/Regulatory compliance related activities as deemed necessary. The role will require a high degree of flexibility to coordinate the variety of tasks.
A minimum of a certificate in a Quality/Science or related discipline and at least 2-3 years practical and relevant experience working in a Medical Device Operations environment
•A “self starter” in terms of time and task management and operate with minimal supervision
•Strong problem solving ability
•Competent with Microsoft Excel/ Access for trending and data analysis
•Good communicator both verbally and in writing with ability to influence
Typical office environments, with work also performed in R&D and manufacturing labs, and customer/supplier locations.
For further information on this Quality Technician role in Galway please contact Tommy Mckeown on 086 0100903 / firstname.lastname@example.org
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