Quality Manager
- Chichester
- Permanent
- Full-time
- Experience of operating and being responsible for management systems within pathology laboratories to ISO 15189 standards.
- Minimum 2 years’ experience in either ISO 15189, ISO 9001 or ISO 17025 accredited environments.
- Auditing experience
- Experience and understanding of root cause analysis
- HCPC registered Biomedical Scientist status
- Qualification in quality management
- Experience of cellular pathology, molecular techniques, sequencing and genomics.
- Experience with GCP/clinical trials
- Familiarity with Q-Pulse
- Experience in risk management, ISO 27001 or DCB 0129/0160
- Performing audits of the management system, managing the audit schedule and making sure this is complete on time for The Courtyard Laboratory.
- Management of the Q-Pulse eQMS system:
- Workflow module (incident reporting/CAPA).
- Audit Module
- Document module
- Customer & Supplier modules
- Asset modules
- Administration
- Process improvement and incident & complaint management.
- Incident investigation and root cause analysis, including supporting other departments in the business to complete investigations appropriately, ensuring corrective and preventive actions are effective.
- Writing, and review of quality policies, SOPs and documents.
- Quality review and approval of documents across the business and ensuring appropriate document control is implemented.
- Ensuring the validation and verification policy is adhered to, ensuring there is a process in place for performing equipment, procedures, methods and software validations/verifications and maintaining in a validated state.
- Support the Clinical Risk Management process through integration into the management system and management of risk assessments and failure modes effects analysis.
- Contributing to the Annual Management Review (AMR) and preparing quality reports.
- Produce monthly quality reports, reporting on KPIs and quality objectives for The Courtyard Laboratory.
- Supporting the business in achieving quality objectives – ensuring these are set, monitored and actioned.
- Co-ordinating the internal awareness of the needs and requirements of the users through the AMR, assessment and audit feedback, complaints, incidents and KPI/quality objectives.
- Provide training for staff undertaking quality related activities, as required. (e.g., training in performing audits and root cause investigation).
- Liaise with, lead and support accreditation and certification assessment visits and responses at The Courtyard Laboratory.
- Support any third-party audits by regulators or clients.
- Supporting quality leads within departments and at other sites within the business, with occasional travel if necessary (such as performing audits).
- Provide training for quality leads and any other staff undertaking quality related activities, as required.
- Deliver the expectation of the service users whilst also balancing the interests of the company.
- To lead by example, demonstrating professionalism to colleagues commensurate with post.
- To comply with safe working practises in accordance with Company safety policies
- To participate in the Annual Joint Staff Review process, in accordance with Company Policy.
- To perform any other duties as may be reasonably required commensurate with grade and experience.
- Attend any training endeavours as appropriate to the role or as reasonably requested by Line Manager.
- Life Assurance x4 salary
- Employee Assistance Programme
- Medicash health cash plan
- Shopping & leisure discount portal
- Virtual GP Service
- mProve Yourself health and wellbeing resources
- SkinVision App
- Able Futures Mental Health support
- 33 days holiday (inclusive of bank holidays) increasing with LOS
- An extra day off on your birthday
- Option to buy and sell holidays
- Cycle to work scheme
We are sorry but this recruiter does not accept applications from abroad.