Job Description

We are currently working with a leading orthopaedic device manufacturer who has asked us to help them locate an experienced Quality and Regulatory Manager to help them manage and progress their quality function which is based out of their Global HQ here in the UK.

The role will be responsible for the successful day-to-day operation of the Quality Management system, supporting and leading quality improvement initiatives and responsible for ensuring that all managers, process owners and supervisors develop and maintain their part of the Quality Management System.

 

The main duties for this role will be, but not limited to:

  • In conjunction with the QA & RA Director, organise, develop and maintain the Company QA/RA activities in accordance with  the Company Quality Assurance system and ensure all members of staff are familiar with and comply with such requirements
  • Deputise for the QA and RA Director where permitted by procedures including acting as the Deputy Management Representative as defined in ISO13485 and 21CFR820
  • Work with the QA & RA Director to maintain a full accreditation under current and foreseeable EU and FDA Directives for medical devices related to orthopaedics, as necessary
  • Plan and manage all internal and external audit processes both by and of the Company

 

To be considered for this position the successful candidate will need to have at least 8 years quality assurance experience within a manufacturing environment, preferrably with Medical Device sector. It is essential though you have at least 3 years team leadership exposure..

Ideally the successful candidate will come from an engineering background with excellent communication skills.

   

 
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