Quality Manager – ISO 13485 Medical Devices

Full Time Nottinghamshire IT Job Pro UK

HOMEBASED ROLE – some ad hoc travel
This is an exciting and new opportunity to join a clinical software company and take responsibility for the company's ISO13485 (medical devices) quality management system and MHRA compliance; this includes creating and developing a brand new QMS that is ISO 13485 compliant.
The Quality Manager role involves:
* Developing & executing the corporate quality assurance system for medical devices / manufactured software products to ISO 13845 regulations & standards
* Maintaining compliance to ISO 13485 and MHRA standards
* Supplier contracts and audits
* Internal audits
* Documentation control
* Development of standard operating procedures
* Develop and implement a CAPA system
* Employee training on the quality system and MHRA requirements
* Review trends associated with manufactured software
Key requirements:
* Solid and recent experience of ISO 13485 quality system requirements, including design controls
* Proven ability to develop, implement and maintain a quality system
* Drive continuous improvement
* Knowledge of software development
* Degree qualified
* 3 years experience in a Quality manager role involving ISO 13485
* Certified quality engineer is desirable although not essential if you meet all the other criteria
This role will be an integral part of the clinical safety team working together to ensure the technical products are compliant with regulations. The role offers interesting and challenging work and long term career opportunity.
To apply please send your CV with details of the relevant experience

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