Quality Engineer REPORTING TO:QualityManager This role would be onsite based in Shannon JOB PURPOSE:Develop,establishand maintain quality systems and practices which meet the company,customerand regulatory requirements. PRINCIPALACCOUNTABILITIES: Ensurecompliancewithallpertinentregulations(e.g.FDA,ISO) Ensure compliance and execute activities to the QMS such as non-conformance investigations,CAPA,Changecontrol,complaints,documentcontrol,andrecordretention. SupportDHRreviewstoensuretimelyreleaseofproduct Develop,implementandmaintainproceduresandforms. Support production activities in building quality into products and assuring compliance to the pertinent regulations Leadand executeupgradestothequalitysystem Participation,co-ordinationand maintenanceof theauditsystem. Supportcustomerandregulatoryaudits Ensuringthepromotion ofthe awarenessof customerrequirements inthecompany. Producing daily management reports with a view to identifying and making recommendations on improvement opportunities. KNOWLEDGE/EXPERIENCE: Bachelorsdegree ina scientificdisciplineis anadvantage Minimumof3yearsinaQualityAssuranceroleinMedicalDeviceorPharmaispreferred. Excellentverbalandwrittencommunicationskills Abilitytoworkinacrossfunctionalteam Goodcommandof MSOfficeWord,Excel,PowerPoint Workingknowledgeandunderstandingof QSR andISOqualitysystemrequirements LeadAuditorcertificationorpreviousauditingexperienceispreferred Benefits: Pension