NES Fircroft is actively recruiting a Quality Engineer for a Global Medical Device manufacturer in Westmeath.
This is a contract role with an immediate start date on offer.
Job Description
* Provide Quality Assurance support to ensure the Quality System is of the highest standard with particular focus on validations and non-conformances.
* Implement and maintain quality system to the international standard ISO 13485, ISO 9001 and all applicable regulations under the Medical Device regulation, including creation of new SOP’s and revision of existing documentation within the quality management system
* Carryout internal audits to the ISO 13485 standard.
* Partake as a key team member in customer and regulatory audits as required.
* Product Development: Participate in and support all aspects of new product development, production trials, sampling and production runs of new materials and finished products as needed.
* Monitor vendors and issue NCMR’s where necessary and ensure problem vendors are identified and controls implemented to prevent problem reaching products.
* Report on relevant quality performance data and drive continuous improvement processes within the organisation through change control activities.
* Manage investigation and closure of Validation Deviations, Non-conformances and CAPA’s, including support of the investigation processes when not the owner.
* Validation: Assist with the generation and execution, where required, of validation protocols and reports (IQ/OQ/PQ), including data analysis and test scripts as required.
Person Specifications/Desirable
* Bachelor’s Degree in Science, Engineering or a related field
* Experience working at quality engineer level in an ISO 13485 regulated environment.
* Internal Auditor qualified to ISO 13485
* Experience with equipment validation and statistical analysis is essential.
* Strong interpersonal, problem solving and attention to detail skills.
This is a site based role so please only apply if you are able to commute daily to Westmeath
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