Quality Systems Manager 0.5FTE

University of Dundee - Medicine Office

Summary of Job Purpose and Principal Duties

Day to Day Reporting to/Reporting Line Manager: Operations Lead

Duration: Two years fixed in the first instance

The Division researching in Medical Science and Technology (MSaT) within the Medical School at Dundee University currently has ISO13485 accreditation for “design and development of medical devices for minimal access surgery” by the Surgical Technology and Robotics Group headed by Prof Sir Alfred Cuschieri, and the retention by the Group of the new revised ISO 13485 certification would be the main priority of the new QMS Manager.

This accreditation is important strategically for MSaT as it simplifies the translation of their research products into clinical evaluation. It also increases the opportunities for partnerships with industry.

The role holder is responsible for the implementation and monitoring of the MSaT Quality Management System (QMS), and will act as the Quality Management Representative.

Summary of Skills, Experience and Qualifications

Knowledge, Skills and Abilities:

  • Strong liaison skills, with the ability to manage complex relationships with a wide range of individuals within the University.
  • Interpret and implement University policies and procedures.
  • Excellent communication and organisational skills.
  • Excellent interpersonal skills, including evidence of team working.
  • Ability to balance competing demands and prioritise effectively, working to tight deadlines and to make independent decisions.
  • Responsible for prioritising own workload both proactively and flexibly to take into account competing and shifting demands.
  • Monitoring own progress on activities and working on own initiative within overall remit to implement/progress short, medium and long term objectives.
  • Appreciation and understanding of data protection, confidentiality, equality and diversity legislation.
  • Ability to work autonomously and clearly communicate complex, specialist information both orally and in writing.

Experience Required:

  • Knowledge of the Higher Education environment.
  • Qualified to HNC or Degree level in engineering or another relevant scientific discipline.
  • Extensive professional experience in regulatory affairs or in quality management systems.
  • Experience of GLP and ISO 13485.
  • Experience of acting as a principal point of contact for all QMS queries.
  • Experience of working within a research environment.
  • Working knowledge of all aspects of H&S.

Additional Information

The University of Dundee is a diverse community and is committed to equality of opportunity for all by providing a supportive, flexible and inclusive working environment. We have family friendly policies (including flexible working and childcare vouchers), staff groups for LGBT and BME; and prayer room facilities.

The University of Dundee has received the Athena SWAN Bronze Award (Athena Swan) which recognises the promotion of gender equality and has made further commitment to advancing inclusive culture which supports and encourages all under-represented groups.

The University of Dundee is a Scottish Registered Charity, No. SC015096.

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Scotland