Posted 5 months ago

Quality Manager

Inspire Resourcing Ltd are seeking a Quality Manager for a rapidly expanding company on the outskirts of Chesterfield. The role of Quality Manager is key to the successful delivery of medical supplies.  

The Job Summary:

The Quality and Regulatory Affairs Manager is responsible for creating and implementing medical products quality management strategy and processes to support organisational growth plans in all aspects of design, manufacturing, and release of the company’s product portfolio.

Main Duties and Responsibilities:

  • Act as the Management Representative as defined in ISO 13485:2016
  • Chair management review meetings
  • Ensure global compliance with legislation governing the quality system
  • Manage relationships with Notified Bodies and Competent Authorities
  • Responsible for product and process risk management and mitigation
  • Responsible for regulatory submissions and market clearance activities
  • Monitor and communicate updates from the global regulatory arena
  • Manage the medical products vigilance system
  • Review and approve company literature with Author
  • Manage the compliance of the Quality management system
  • Manage Internal Audit Process
  • Manage the CAPA process
  • Assisting of company product design, manufacturing and distribution operations
  • Maintain production and design history files
  • Attend management review meetings
  • Ensure the completion, maintenance and safe storage of all quality documentation (e.g. the DMS)
  • Ensure that processes needed for the QMS are established, implemented and maintained
  • Ensure Quality Objectives are established and reviewed
  • Implement and drive design quality assurance
  • Assist with issues management (complaints)
  • Schedule and drive product related preventative and corrective action
  • Managing internal and external audits of the QMS
  • Implement a continuous improvement process driven by defined key performance indicators that feed into the management review process
  • Drive all elements of software quality assurance support to manufacture a range of medical devices; including product development, manufacturing operations, information systems, and quality systems activities
  • To apply for the Quality Manager role the ideal Education & Experience would be:

    • Degree in Engineering, Design or related discipline
    • 5+ years’ experience in Quality Engineering, information systems or management preferably in a regulated industry
    • One year in a leadership role for product software validation and software quality assurance activities. (desirable not mandatory)
    • Working experience of regulations relating to in-vitro diagnostic medical device products and software (e.g. FDA’s “General Principles of Software Validation and “Guidance for the Content of Premarket Submission for Software Contained in Medical Devices, 21CFR Part820, 21CFR Part 11, EN ISO 13485, IEC 60601, EN ISO 14971:2012, IEC 62304)
    • Experience with CE technical files
    • Experience in Software Development Life Cycle activities and understanding of software design inputs and outputs
    • Working knowledge of product software, analytical process software, manufacturing process software, and quality system software validation methods and requirement
    • The salary: 45-50K depending on experience.

      Hours: Monday to Friday (flexible days) 38.5 hours 

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