Senior Quality Systems Engineer - Contra
Senior Quality Systems Contractor. Responsibilities: Act as SME for internal auditing, CAPAs, complaint handling and supplier quality activities. Specifically, this will mean acting as CAPA Administrator for the site and assisting CAPA champions. Monitor progress of CAPAs and escalating any serious issues to senior management while also compiling monthly reports. Work closely with supplier quality, complaints and QA providing guidance and assistance as needed, implementing continuous improvements. Host monthly quality meetings to track actions and to liaise with product complaints, acting as the plant contact. Work cross functionally with design QA and Complaints to undertake health hazard assessments where needed. Act as SME for internal auditing and assist the internal audit team to plan audits and to coordinate corrective action plans. Provide assistance in training internal auditors with regard to relevant regulations. Analyse trends for CAPAs, Complaints, Internal Auditing and Supplier Quality KPIs. Requirements: Third level degree in quality or relevant discipline. Must have a good understanding and working knowledge of ISO 13485, FDA QSRs, JPAL and Canadian Medical Device regulations. Strong analytical skills. Five years or more experience in quality engineering, preferably quality systems. Lead auditor qualification is preferable but not required. To apply for this position please contact James Porter at Sigmar RecruitmentT: +353 91 455305E: email@example.com. All applications will be treated with the strictest of confidence. Sigmar will never forward your CV to a third party without prior consent. Following your application for this specific role, Sigmar may contact you regarding other positions that we feel you may be suitable for. If you do not wish to be contacted about other opportunities please let us know. For further information please refer to the Privacy Statement on our website. This job originally appeared on RecruitIreland.com.
73 days ago