Quality Manager
- West London
- £56,276-63,176 per year
- Permanent
- Full-time
- Ensure the QMS is fully embedded within laboratory operations, meeting ISO15189:2022 standards and supporting departmental objectives.
- Effectively manage and prioritise tasks to support the implementation and maintenance of the QMS.
- Develop an annual audit plan aligned with ISO15189:2022, and report findings to the Senior Management Team and Laboratory Director.
- Ensure all audit outcomes are thoroughly investigated, actioned, and closed within agreed timelines.
- Promptly investigate incidents (e.g., Datix reports), result errors, and service user complaints with the Laboratory Manager, identifying root causes and implementing corrective actions.
- Ensure preventive actions and process redesigns are carried out effectively to prevent recurrence and enhance service quality.
- Have knowledge of working in a clinical laboratory environment.
- Familiarise with and be knowledgeable in the use of Liquid Chromatography-Mass Spectrometry (LCMS).
- Train staff in QMS and their responsibilities within the QMS, ensuring understanding of ISO15189:2022 and UKAS standards.
- Provide training on audit processes to support internal audit delivery and promote a culture of quality.
- Oversee the department CPD programme and that CPD activities are appropriately recorded.
- Hold regular meetings with staff to review and support CPD ensuring alignment with professional standards.
- HCPC Registered
- IBMS accredited honours degree in Biomedical Sciences or IBMS equivalent
- FIBMS or MSc in an appropriate science
- Quality Management qualification or working toward
- Experience in the use of Quality Management Systems in a diagnostic laboratory
- Experience in using Q-Pulse at an advanced level
- Experience of using a LIMS system
- Experience of working as a Band 6 Healthcare Scientist (as a minimum)
- Experience in incident reporting, non-conformance and root cause analysis
- Experience in performing audits and managing findings
- Experience with writing and reviewing policies/SOPs
- Good knowledge of QMS, accreditation processes, and a good understanding of the ISO15489:2022 standards
- Proven involvement in UKAS assessments, including preparation, active participation during inspections, and post-assessment follow-up to address findings and maintain accreditation
- Experience of teaching and training staff
- Experience of validation/verification
- Experience of leading UKAS assessments
- Experience of working in a therapeutic drug monitoring laboratory
- Experience of managing staff
- Experience of operating specialist clinical laboratory equipment
- Experience of performing LIMS User Acceptance Testing
- Experience of using Q-Pulse CAPA and Assets modules
- Intermediate Microsoft Office user and data analysis skills
- Excellent communication skills, both oral and written
- Time management and prioritisation skills
- Strong organisational and planning skills.
- Be methodical and have high attention to detail
- Be self-motivated and use initiative
- Good interpersonal skills
- Leadership skills with ability to motivate staff
- Work as part of a small team
- Knowledge of QMS, audit, CAPA and RCA processes
- Knowledge of IQA and EQA
- Knowledge and understanding of staff competency assessment
- Knowledge of organising audit schedules
- Ability to train and competency assess staff in QMS processes
- HCPC Registered
- IBMS accredited honours degree in Biomedical Sciences or IBMS equivalent
- FIBMS or MSc in an appropriate science
- Quality Management qualification or working toward
- Experience in the use of Quality Management Systems in a diagnostic laboratory
- Experience in using Q-Pulse at an advanced level
- Experience of using a LIMS system
- Experience of working as a Band 6 Healthcare Scientist (as a minimum)
- Experience in incident reporting, non-conformance and root cause analysis
- Experience in performing audits and managing findings
- Experience with writing and reviewing policies/SOPs
- Good knowledge of QMS, accreditation processes, and a good understanding of the ISO15489:2022 standards
- Proven involvement in UKAS assessments, including preparation, active participation during inspections, and post-assessment follow-up to address findings and maintain accreditation
- Experience of teaching and training staff
- Experience of validation/verification
- Experience of leading UKAS assessments
- Experience of working in a therapeutic drug monitoring laboratory
- Experience of managing staff
- Experience of operating specialist clinical laboratory equipment
- Experience of performing LIMS User Acceptance Testing
- Experience of using Q-Pulse CAPA and Assets modules
- Intermediate Microsoft Office user and data analysis skills
- Excellent communication skills, both oral and written
- Time management and prioritisation skills
- Strong organisational and planning skills.
- Be methodical and have high attention to detail
- Be self-motivated and use initiative
- Good interpersonal skills
- Leadership skills with ability to motivate staff
- Work as part of a small team
- Knowledge of QMS, audit, CAPA and RCA processes
- Knowledge of IQA and EQA
- Knowledge and understanding of staff competency assessment
- Knowledge of organising audit schedules
- Ability to train and competency assess staff in QMS processes