Quality Manager - Facilities Management

Facilities Management scope of operation is far reaching and has multiple touch points on the Groups Laboratories, where, if failure occurs, can lead to accreditation non-compliance, and ultimately can impact quality of service and patient safety. The purpose of this role is to administer and monitor the quality management system (QMS) within the Facilities Management (FM) directorate. To develop the QMS for the FM and Laboratory Support teams to create a culture of quality and getting it right first time. To oversee local Quality activities in accordance with good practice and appropriate accreditation or regulatory bodies e.g. ISO, MHRA, GXP etc The role would have QM remit over all Laboratory Services functions including procurement, goods in and out, kit making, asset management, supplier compliance, Engineering and Sample Storage. To include, but not be restricted to, the following duties - 1. To maintain and implement the Quality Policy for the department as directed. 2. To be
responsible for retaining, maintaining and continuously improving, the QMS in the department. 3. To establish key quality indicators for overall analysis and trending and to identify opportunities for improvement to be actioned. 4. To have specific responsibility for quality oversight of the QPulse asset module, including auditing of asset management. 5. To support supplier compliance officer with quality review and sign offs of supplier approval. 6. To keep under review and update manufacturing safety notices. 7. To manage incident training for FM/LS staff, incident investigation, corrective and preventative actions plan, lessons learned and driving improvement. 8. To organise and contribute to QMG meetings including annual management review. 9. To assist with the identification and establishment of quality objectives and Quality Indicators, including formulating a plan for achieving these against appropriate and relevant timescales. 10. To be responsible for the establishment of and
monitoring of a risk-based audit program to cover FM functions. This should include requirements of ISO15189 where appropriate and any other appropriate or relevant standards (e.g. ISO 13485, ISO9001) 11. To support with change control training, embedding change culture, approving change action plans, risk assessment and supporting communication on change. 12. To train and advise staff on verification and be the link person between FM and laboratories with respect to changing and/or verification of new products 13. To ensure compliance and maintenance of document control system for the department. 14. To ensure prompt response to enquiries and any follow up, including incidents, investigations and complaints. To ensure timely preparation of any summary and investigation reports, in accordance with the requirements of HSL QMG and compliance services. 15. To manage and where appropriate, deliver, the training programme for FM/LS staff in quality management systems 16.
To engage in activities associated with measuring and monitoring performance of the department including monitoring of key activities (Kelsius trending, cold storage, disposal of samples, saves records etc.) 17. To support risk management, identification and mitigation of risks and the departmental risk register 18. To ensure all quality related processes are performed in accordance with the relevant Health and Safety procedures. 19. As required, to provide support to other Group departments 20. To monitor levels of compliance in areas of responsibility in order to identify actual and or potential risk that may require escalation and take appropriate action