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- Lead the Clinical Governance and Quality Team to identify and manage Risk.
- Ensure compliance with relevant legislation and regulations across the organisation.
- Ensure that all managers and responsible individuals develop and maintain the quality management system for which they are accountable.
- Assist in the management of non-conforming work identified and ensure that incidents are managed in line with documented procedures.
- Lead the management of complaints and customer enquiries and ensure they are recorded and progressed in line with documented procedures.
- To plan, conduct and manage CAPA of internal Quality audits for ISO9001 and applicable healthcare regulatory requirements (CQC, HIS, HIW).
- Manage internal audit schedule and auditors.
- Monitor clinical documentation through Q-Pulse to ensure compliance with QMS and regulatory requirements.
- Conduct process and supplier internal audits where required to ensure compliance with relevant standards, in particular ISO17025 and ISO15189.
- Attending Department Quality & Technical Review meetings.
- Manage the trending of Key Performance Indicators (KPIs) including trending of opening and close out of NCPs, Quality incidents and CAPAs.
- Lead external audits and inspections, being the primary point of contact between the organisation and auditors or inspectors.
- Champion, support, and lead quality improvement initiatives across the organisation.
- Working alongside the Operational team, participate in special projects and initiatives. The Candidate:
- Educated to degree level (Min 2:1).
- At least two years' experience as a Quality Manager.
- At least two years' experience of implementing a quality management system in a regulatory environment.
- Possess excellent verbal and written communication and organisational skills.
- Demonstrate excellent attention to detail.
- Computer literate.
- Knowledge of a variety of software packages, such as Microsoft Word, Outlook, PowerPoint, & Excel to produce correspondence and documents and maintain presentations, records, spreadsheets, and databases. Desirable:
- Experience and interest in healthcare or related industry.
- Experience in Quality Managements Systems i.e., ISO9001 / ISO17025 / ISO15189 / GCP.
- Good troubleshooting skills.
Health Quality Manager - Crumlin, United Kingdom - Randox
Description
The Role:
Essential: