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Senior QE

Job Title: Senior QE
Contract Type: Permanent
Location: Galway
Industry:
REF: 83981
Job Published: over 1 year ago

Job Description

Senior Quality Engineer

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.

Key Responsibilities
? 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.

Role Requirements
? 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 / cliona@hero.ie
Check out all our open jobs on our HERO Recruitment website ? www.hero.ie

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