We have a vacancy for an enthusiastic, self-motivated Quality Manager who can lead and monitor quality aspects within the rapidly expanding Hertfordshire and West Essex (HWE) Cellular Pathology service at Health Service Laboratories (HSL). This is an exciting opportunity to join the team during department transformation with 3 different hospitals. The location scope includes Hemel Hempstead Hospital, Lister Hospital, and Princess Alexandra Hospital.
You will be a key member of the department, developing and maintaining quality systems, working with the laboratory team and quality representatives to deliver the quality policies and objectives at HSL.
The post holder will have post graduate qualifications in Biomedical or Life Sciences and have significant experience of working as a quality lead in a Cellular Pathology laboratory with experience of laboratory UKAS accreditation and HTA Inspections. Good organisational and communication skills are essential.
Main duties of the job
Main duties will include administration, monitoring & implementation of the Quality Management System (QMS) and to oversee quality & compliance activities. Other duties include QMS training across group and to assist in the organisation of and chairing the departmental Quality Management Group meetings.
Job responsibilities
Main duties to include, but not be restricted to, the following duties:
1. To be responsible for retaining, maintaining and continuously improving the QMS in the pathology departments.
2. To maintain and implement the Quality Policy for the HSL laboratories as directed.
3. To be responsible for the timely review and application of the Quality processes and documentation.
4. To organise and contribute to the QMG meetings.
5. To organise and contribute towards the timely and effective running of the Management Reviews held routinely across the Group.
6. 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.
7. To assist in maintaining and further developing systems to facilitate the Continuous Improvement activities across the HSL Group.
8. To be responsible for the planning, organising and execution of an effective audit schedule for the department, with support for other Group aligned departments where necessary.
9. To be responsible for the preparation, administration, dissemination and routine review of the quality manual.
10. To ensure compliance and maintenance of document control system for the laboratories.
11. To ensure prompt response to enquiries and any follow up, including incidents, investigations and complaints.
12. To ensure timely preparation of any summary and investigation reports, in accordance with the requirements of HSL QMG and compliance services.
13. To support and participate in the training of departmental staff in all Quality related activities.
14. To contribute towards and participate in the ongoing evaluation and improvement processes for the HSL laboratories.
15. To engage in activities associated with measuring and monitoring performance of the HSL laboratories.
16. To assist and support the harmonisation of processes and procedures (both quality & operational) for the department across sites within the HSL laboratories.
17. To ensure all quality related processes are performed in accordance with the relevant Health and Safety procedures.
18. As required, to provide support to other HSL laboratories.
19. 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.
Person Specification
Qualifications
* First degree in Biomedical or life sciences.
* Qualification in Quality Management or equivalent experience of working as part of or leading a quality management team.
* Post graduate degree in biomedical sciences. Registration with HCPC is not essential but is desirable.
Experience
* Significant experience of working as HCPC registered Biomedical Scientist within a Biochemistry laboratory.
* Previous experience of leading on inspections for laboratory regulatory and assessment purposes.
* Significant experience required in Incident identification, investigation, root cause analysis and CAPA management.
* Auditing qualification or significant experience.
Depending on experience Up to £54,000 DOE, inc. HCA
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