Job Description

You will be responsible for general maintenance of the Quality Management System (QMS) and supporting the QA Manager in maintaining compliance standards.

Key Responsibilities:

• Support continuous improvements in the Quality Management System (QMS) and maintain compliance of Quality processes
• Work with the managers and their teams to maintain all aspects of the QMS e.g. Change Controls, Non-Conformities, CAPAs, Customer Complaint
• Provide support as required for notified bodies and client audits, as well as performing internal audits according to schedule
• Perform desk-based and on-site audits of subcontractors and suppliers
• Working with other QA staff, provide support to Operations team, e.g. report review and QA statements, as well as assisting in training of personnel on matters relating to the QMS.
• Maintain thorough knowledge and understanding ISO 15189 requirements, Regulatory expectations and guidance documents as these pertain to the work performed at the site

Required Knowledge, Skills, and Abilities

Significant experience of operating within ISO Quality Management Systems of operational laboratory environments and 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. Experience liaising with stakeholders regarding quality and compliance. Experience conducting audits and hosting external auditors. Experience with Ideagen Qpulse Quality Management System.