Quality assurance Technical service Officer

Baxter ,
London, Greater London
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Job Description

We are currently looking for a Quality assurance Technical service Officer, to work from our high performing Northampton National Distribution Site. Summary: * Ensuring processes and procedures for Global Services Operations in UK/ Ireland are in compliance to regulatory requirements, to Corporate Quality Manual and to the ISO 9000 and 13485 requirements * Actively participate in the design, implementation and/or maintenance of the quality processes in the field service operations and service center operations for UK/ Ireland. * Ensure quality assurance compliance in the FA, customer care, field and service center operation processes. * Maintain a strong relationship with the local Global Services team (field operations and service center operations), QATS EMEA Team and relevant Stakeholders (CQA, SQA etc). Essential Duties and Responsibilities: * Quality support to Field Service operation activities in UK/ Ireland cluster * Quality support to Service Center operation in UK * Global Services Quality Systems Local Process Ownership: documentation, procedures, training, internal and external audit, CAPA and non-conformities, post marketing surveillance activities (product complaints, medical device vigilance, and Field Actions), supplier qualification, validation process (IQ, OQ, PQ protocols), change control process and risk assessment * Support and ensure compliance of field and service center operations processes in UK/ Ireland: Device Release, Labelling, Storage areas, Calibration, Decontamination, Equipment Validations, Repair, PM, Spare parts management * Quality KPIs- trending and actions (use of TS systems) * Local QMR for Global Services UK/ Ireland * Support or lead local and/or European projects. Minimum 1-3 years experience in quality management in a medical device or technical service organization - quality processes related to service activity /OR/ experience in technical service/ manufacturing environment Medical Device or Electro-mechanical**products Job: **Quality* Organization: **Global Quality - Global Service Quality* Title: Quality assurance Technical service Officer Location: GBR-London-Northampton Requisition ID: 19000423

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