Quality assurance Technical service Officer
Baxter
Northampton, UK
2d ago

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

    Qualifications

    Minimum1-3 years experience in quality management in a medical device or technicalservice organization quality processes related to service activity

    experiencein technical service / manufacturing environment

    Medical Device or Electro-mechanicalproducts

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