Quality Assurance Technical Service Officer

Quality Assurance Technical Service Officer

A multinational Pharmaceutical company is looking for a permanent Quality Assurance Technical Service Officer to join their Northampton site. The Quality Assurance Technical Service Officer will be reporting into Head of QA and will be responsible for supporting the field services engineers and the in house engineers service products on site from a Quality perspective.

Quality Assurance Technical Service Officer's responsibilities include:
  • 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 centre operations for UK/
  • Ensure quality assurance compliance in the FA, customer care, field and service
    centre operation processes.
  • Maintain a strong relationship with the local Global Services team (field operations
    and service centre operations), QATS EMEA Team and relevant Stakeholders (CQA,
    SQA etc.)
  • 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 centre operations processes in
    UK/ Ireland: Device Release, Labelling, Storage areas, Calibration, Decontamination,
    Equipment Validations, Repair, PM, Spare parts management
  • Support or lead local and/or European projects.

You will be degree qualified preferably within a Scientific or engineering based qualification, with a mminimum  of 1‐3 years’ experience in quality management in a medical device or
technical service organisation. Alternatively experience within a technical service/ manufacturing environment or Electro‐mechanical would suffice.

Application via CV

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