OverviewPE Global is currently recruiting a QA Validation Engineer for a permanent role with a leading international manufacturing client based in County Westmeath. This is a full onsite role.Role: Provide Quality Assurance support to ensure the Quality System is of the highest standard with particular focus on validations and non-conformances. This position will report directly to the Quality Plant Manager.ResponsibilitiesImplement 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 systemCarry out internal audits to the ISO 13485 standardPartake as a key team member in customer and regulatory audits as requiredProduct development: Participate in and support all aspects of new product development, production trials, sampling and production runs of new materials and finished products as neededMonitor vendors and issue NCMRs where necessary and ensure problem vendors are identified and controls implemented to prevent problems from reaching productReport on relevant quality performance data and drive continuous improvement processes within the organisation through change control activitiesManage investigation and closure of validation deviations, non-conformances and CAPAs, including support of the investigation processes when not the ownerValidation: Assist with the generation and execution, where required, of validation protocols and reports (IQ/OQ/PQ), including data analysis and test scripts as requiredEducation/ExperienceBachelor’s Degree in Science, Engineering or a related fieldMinimum 3 years experience working at quality engineer level in an ISO 13485 regulated environmentInternal Auditor qualified to ISO 13485Experience with equipment validation and statistical analysis is essentialStrong interpersonal, problem solving and attention to detail skillsThe above is not exhaustive. Other duties and responsibilities may be added as the employee’s immediate supervisor deems appropriateHow to applyInterested candidates should submit an updated CV. Please click the link below to apply, call Kellie on 086 0200448 or alternatively send an up to date CV to kellie.hackett@peglobal.netPlease note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in IrelandDetailsSeniority level: Mid-Senior levelEmployment type: Full-timeJob function: Staffing and RecruitingReferrals increase your chances of interviewing at PE Global by 2xAthlone and Bigmeadow, County Westmeath, Ireland 2 days ago
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