We are seeking a talented individual to join our QA function and to be responsible for the day to day running of the Quality Management System in our world class medical devices development consultancy.

The QA manager will be responsible for further developing our ISO 13485:2016 QMS in order to drive excellence in our medical device development services. This will require a pragmatic approach to balance our systems with those of our clients, as well as meeting the requirements of the regulator and our client’s commercial goals.

The QA Manager reports to the Quality Director and success in the role will require proactive collaboration with colleagues from across the business.

Key Duties:

  • Continuously develop the QMS, including the implementation of systems supporting the QMS (e.g. eQMS) in compliance with applicable regulations
  • Own and lead pragmatic application of the QA process to suit a broad range of services and clients
  • Manage the internal audit process
  • Support client audits and ISO certification audit
  • Lead the QMS Management Review process, implement actions from the review
  • Work with the Quality Director to implement continuous improvement through leveraging of best practices and benchmarking against industry leaders to ensure the company’s quality system is world class
  • Work with the QA team to update and maintain all quality related documentation and processes
  • Train and coach staff on quality procedures and processes, monitor and continuously improve staff engagement with Quality
  • Investigate complaints, non-conformances, manage and verify effectiveness of corrective and preventive actions
  • Work in close collaboration with other compliance process stakeholders such as Quality Engineering, the Device Testing Laboratory Manager, Security, H&S, Business Continuity, Data Protection
  • Provide support to the Quality Director in the development of the QA strategy and extension of the scope of the QMS in fulfilling and anticipating client expectations, and act as deputy to QA Director when required
  • All other QA related activities expected of a management position within a fast-growing SME

Technical / Research Skills

Essential

  • HND in quality or relevant degree, e.g. in engineering or science or equivalent significant QA experience in a relevant industry
  • A minimum experience of 5 years in medical device product development
  • Demonstrable experience in quality assurance in medical devices or IVD field
  • Knowledge of ISO 13485 and/or FDA QSR and Medical Device Directive/ Medical Devices Regulations
  • Experience of developing effective product design and development procedures
  • Experience of project quality management

Desirable

  • ISO13485:2016 lead auditor qualified
  • Knowledge of other QMS; ISO14971, ISO 62366 and 62304
  • Experience in Quality Systems software validation
  • Awareness of industry trends and developments
  • Experience of working in a project based organisation
  • Worked in a consulting environment
  • Experience in preparation of technical files

Consultancy

Essential

  • Structured and methodical problem solving
  • Good communication skills
  • Flexibility
  • Team player
  • Ability to liaise with colleagues at all levels, both technical and non-technical

Desirable

  • Commercially aware

Personal Characteristics

  • Able to work autonomously - reliable, able to take responsibility and manage own time effectively but knows own limitations
  • Calm and clear thinking under pressure
  • Attention to detail and commitment to our quality system
  • Trustworthy and demonstrates integrity
  • Diplomatic and respectful with colleague and clients
  • Positive outlook and shows tenacity
  • Well presented

Application Form





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