Quality / Validation Engineer - County Westmeath

3 weeks ago

Mullingar, Ireland ICDS Group Full time

Quality / Validation Engineer - County Westmeath. In this role you will provide Quality Assurance support to ensure the Quality System is of the highest standard with a particular focus on validations and non-conformances. Key Responsibilities: - 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 SOPs 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 NCMRs where necessary and ensure problem vendors are identified and controls implemented to prevent problem reaching product. - 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 CAPAs, 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. Interested applicants should have a Bachelors Degree in Science, Engineering or a related field A minimum of 3 years' experience working at quality engineer level in an ISO 13485 regulated environment. Ideally Internal Auditor qualified to ISO 13485 Experience with equipment validation and statistical analysis. Strong interpersonal, problem solving and attention to detail skills. Skills: quality engineer quality assurance medical device

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