Senior Quality Engineer

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Title: Senior Manufacturing Quality EngineerLocation: ClareBenefits: Opportunity for career progression, salary, pension, healthcare and yearly bonus. Company:My client are a Medical Device multinational who manufactures and markets products that simplify, automate and innovate complex biomedical tests. Responsibilities:Co-ordinate the Manufacturing Non-conformance process (NC) for all Production areas ensuring compliance to Quality and Regulatory Standards.Lead cross functional teams providing Quality guidance and support.Responsible for the Rework process, ensuring relevant documentation is prepared.Execute the Stop Ship process for finished product released to the marketResponsible for ensuring the Manufacturing Quality Procedures are current and in line with global proceduresInitiate/review/approve document Change Controls (CCFs) and Equipment Change Controls (ECCs)Ensure quality issues are communicated to the management team such that they are aware of any potential problems or opportunitiesReview/approve Validation documentation (e.g. protocols, reports) ensuring compliance to applicable procedures.Generate, update, implement and complete associated training for relevant departmental procedures, as required.Assist in the Supplier Quality process acting as a Supplier Quality representative, if applicableAssist with the QA review & disposition of Batch History Records (BHRs) for all product lines and complete the associated ERP activities ensuring relevant logs and BHRs are maintained.Perform CAPA (corrective and preventive action) activities and document in the Global CAPA system if required. Experience required:Bachelor' s degree in chemistry, biochemistry, engineering or other relevant technical field with a minimum of 3 years' experience in a highly regulated industry.Desirable to have previous experience in IVDDs and Manufacturing Quality.Good knowledge of ISO9001/ISO13485, FDA and GMP requirements.Excellent time management, planning and organisation skills.Must have a working visa for Ireland If you are interested in applying or hearing more about this opportunity and others like it, forward a copy of your update CV. To find out more about Real please visit www.realstaffing.comReal Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales