A laboratory based in Leamington Spa is seeking a Quality Manager for their busy operation.
Purpose of Role:
* Support Accreditation and Quality Assurance matters on site.
* Support the Head of Quality in maintaining compliance of the Quality processes and documentation on site to meet the requirements of the Notified Bodies/UKAS.
* Support continuous improvements in the Quality Management System (QMS)
* Work with the managers and their teams to maintain all aspects of the QMS e.g. Change Controls, Non Conformities, CAPAs, Customer Complaints
* Provide support as required for all Notified Bodies/UKAS and Client audits.
* Work with other QA staff to provide all the support required by the Operations teams, e.g. Work Instruction review, report review, QA statements, training, quality record review.
* Perform internal audits according to the provided schedule.
* Perform desk-based and on-site audits of sub-contractors and suppliers.
* Provide support to ensure timely release of results and audited reports to clinicians.
* Assist in training of personnel on all aspects related to the QMS.
* Support the collection and reporting of monthly Quality KPIs.
* Maintain thorough knowledge and understanding ISO 15189 requirements, Regulatory expectations and guidance documents as these pertain to the work performed on site
* At all times, adopt a safe behaviour by exercising due regard for the health and safety of yourself, colleagues and clients, in line with the Company’s policies and procedures.
Current Challenges and Opportunities:
* Support the development and implementation of a new QMS to ensure that Regulatory requirements are met whilst maximising work throughput.
* Develop and implement SOPs etc.
* Helping to train staff
* Helping to implement a “right first time” culture throughout the site
* Significant experience of operating within ISO Quality Management Systems of operational laboratory environments.
* Experience with ‘Ideagen Qpulse’ Quality Management System would be a preference
* Experience in liaising with internal and external stakeholders on all areas of quality and compliance.
* Experience in conducting audits and hosting external auditors.
* Experience working within a laboratory setting working to relevant ISO accreditation standards; ISO 15189, ISO 17025, ISO 9001.
* A team player, with good analytical reasoning, customer focus, communication and change orientation in a fast paced environment
Quality Management Systems
Product Quality Assurance