Quality Engineer - Ripon, United Kingdom - Real Staffing

Real Staffing
Real Staffing
Verified Company
Ripon, United Kingdom

2 weeks ago

Tom O´Connor

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Tom O´Connor

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Description

Our client is a Medical Device company with over 20 years' experience of design and manufacture of medical device products based in Yorkshire.

They work with surgeons, operating theatres and suppliers and their quality assured products are used in over 72countries and are sold via a carefully selected network of distributors, under world renowned brands.


They are expanding their Quality team and looking to add a Quality Engineer to the department to support the manufacture, sterilisation, packaging and shipment of medical devices.


The Quality Engineer will be responsible for projects associated with process development and continuous improvement, across equipment qualification, process validation, computerised systems validation, risk management and non-conformance investigations.

The Quality Engineer will provide technical quality leadership to manufacturing programmes, in partnership with Production.


Responsibilities:


  • Effective implementation of Master Validation Plans in support of site qualification and validation activities
  • Lead process, computerised systems and cleaning validation programmes
  • Creation and independent review of validation protocols and reports using appropriate statistical methodology
  • Independent review of protocols and reports in support of sterilisation validation.
  • The Quality Engineer will lead generation and independent review of equipment qualifications and gauge R&R studies
  • Provide Quality Engineering input based on engineering principles for a range of projects
  • Lead continuous improvement activities
  • Initiate and lead the investigation of manufacturing product quality and compliance issues
  • Implement corrective and preventive actions and verify their effectiveness
  • The Quality Engineer will lead crossfunctional teams in the creation and development of risk management documents
  • Support the compliant use of equipment maintenance systems
  • Support internal and external (supplier) quality audits

Skills/Qualifications:


  • Knowledge of ISO 13485 or ISO 1497
  • Equipment qualification and process validation
  • Risk management reviews
  • Statistical approach and ability to review systems
Real 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 andWales
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