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