|Job Title:||Senior QE|
|Job Published:||over 1 year ago|
Our client, a company located in West Galway is looking for an experienced Senior QE for a new permanent role. This job requires an experienced and proven candidate with a background in quality assurance of medical devices. The successful candidate will work as part of a team to maintain high quality/performance standards on all products. The Senior QE will be reporting directly to the Quality Manager, the position will be challenging and will require an ability to work autonomously.
? Perform an active role in quality planning and new product introduction including;
? Product and process risk analysis through Process FMEA.
? Design control including product design verification.
? Provide quality assurance input in the creation and review of validation protocols and reports.
? Provide quality assurance review at required project milestones.
? Develop QA Documentation for transition from Design Service to Manufacturing
? Have a working knowledge of the ISO13485, FDA QSR and Medical Device Directive.
? Assist in maintaining the quality management system through;
? Performance of internal audits.
? Championing continuous improvement through CAPA system, Complaint Handling, KPI Analysis, etc.
? Participation in audits ? regulatory body and customer audits.
? Have strong communication, organizational and project planning skills.
? Have the ability to write engineering documents, test protocols, FMEAs, etc.
? Make appropriate decisions on a daily basis, using the Quality Manager as the final arbitrator on critical quality decisions.
? A degree in production engineering, quality engineering, life science or related field
? 5 years? experience in the medical device industry is required.
? Candidate must be highly motivated with good communication skills and the ability to work as a team member.
For further information on this Senior Quality Engineer role in Galway please contact Cliona O?Malley on 091730022 / firstname.lastname@example.org
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