Quality Manager - ISO13485

Rinicare Ltd is an intelligent healthcare company marketing its innovative wireless and computer vision - based products into the healthcare space.  As part of its planned expansion the company is implementing ISO 13485 in its new facility in Manchester building on the pre-existing ISO 9001 and ISO 27001 systems.  The advertised role is for a Quality Manager to implement and manage the QMS to support commercial activities.


The successful candidate will be primarily responsible for:

  • Creation of an appropriate Quality Management System and implementation of ISO 13485
  • Managing all aspects of the internal quality management system
  • Managing and creating the Quality team
  • Liaising with external approval and accreditation bodies
  • Contributing in the global management and business development as a member of the to assist in achieving revenue targets and maintaining regulatory compliance.



  • Significant work experience in positions with significant QA responsibility in ISO 13485
  • Significant medical device or digital health experience
  • Significant auditing experience against recognised standards
  • Interaction / communication with regulatory agencies
  • Demonstrable ability to successfully manage certified quality management systems
  • Knowledge of compliance requirements related to medical digital health and medical devices
  • Effective interpersonal skills, able to develop good working relationships
  • Fluent written and spoken English and ability to write clear procedures
  • Relevant degree or higher qualification.


  • Ability to manage, motivate and coach staff
  • Experience working under own initiative and in planning and prioritising work
  • Medical device auditor status


The role will be based in the Manchester office with significant interaction with Rinicare staff in Lancaster and Portugal.   Salary and benefits will be commensurate with the role and experience of the successful candidate.

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