Vantive
Service Quality Engineer
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Summary
We are looking for a talented Junior Service Quality Engineer to join our amazing Quality team in Northampton.
The incumbent will:
- In collaboration with the Quality TS team Ensure processes and procedures for Global Services Operations are in compliance to regulatory requirements, to Corporate Quality Manual and to the ISO 9001 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 in UK/ Ireland and Nordics cluster
- Ensure quality assurance compliance in the front office/ back office, field and service center operation processes
- Maintain a strong relationship with the Global Services team, QATS EMEA team and relevant Stakeholders (CQA, SQA etc).
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Essential duties and responsibilities:
- Quality support to Field Service operation activities in the UK/ Ireland and Nordics cluster
- Quality support to Service Center operation in the UK
- Global Services Quality System Local Processes Ownership: documentation/ procedures, training, internal and external audit, CAPA and non-conformities, compliance to the 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: Device Release, Labelling, Storage areas, Calibration, Decontamination, Equipment Validations, Repair, PM, Spare parts management
- Quality KPIs- trending and actions (use of QA and TS systems)
- Support or lead Local/ European/ Global projects and initiatives
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Fundamental requirements:
- Experience in manufacturing, R&D or quality operations gained in the Medical Devices sector
- Desirable Degree in Engineering
- Learning by doing and smart attitude
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