Quality Manager

3 weeks ago

Crumlin Co Antrim, United Kingdom Energy Jobline CVL Full time

We have an exciting opportunity to join our Quality Control team within our ever-growing Randox Heath Clinic network, providing Quality Assurance leadership in the management of non-conforming work identified within Randox Health Clinics under the direction of the Head of Operations to development, and implementation of Quality projects to develop and maintain the QMS established within Randox Health Clinics and associated tasks.

The Role:

* 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:

Essential:

* 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.

About Randox Health

For almost 40 years Randox has been at the forefront of clinical diagnostics, dedicated to improving health worldwide with our disruptive technology and innovative diagnostic solutions. This experience and expertise powers each of our state-of-the-art Randox Health clinics, currently located in London, Liverpool, and Northern Ireland, with ambitious plans to roll out a number of new clinics in the coming months and years. A mobile service enabling certified Randox Health staff to visit clients at their convenience is also available.

At Randox Health we encourage individuals to adopt a personalised, preventative approach to their health and well-being, ultimately helping them to live healthier for longer. Using Randox revolutionary technology we measure hundreds of health biomarkers, generating unrivalled data that when combined with our complex algorithms can predict future health concerns and identify early signs of illness even before symptoms arise. This empowers individuals to act sooner to prevent or delay disease onset – moving from a model of sickness management to true preventative healthcare. Our unique biomarker tracking service allows you to establish a health baseline from which you can track and monitor improvements over time.

In early 2020, Randox were one of the first to respond to the coronavirus pandemic, developing a pioneering diagnostic test for COVID-19 in just a few weeks. Our rapid COVID-19 testing service is trusted and used by a variety of private companies, individuals, and by the sports industry, and in the UK Government’s COVID-19 Testing Programme.

Randox Health is an Equal Opportunities Employer #J-18808-Ljbffr

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