Keith McMillan
Dr – QualitySenior Quality Officer
Draft Quality plans and review Technical Quality agreements and Contracts
Work with the Program/Project/ Department Managers and their teams to maintain all aspects of the
QMS as we develop our diagnostic capability e.g. Change Controls, Non-Conformities, Deviations,
Customer Complaint.
Provide support as required for notified bodies and client audits, as well as performing internal audits
according to schedule.
Perform evidence-based audits of sub-contractors and suppliers.
Provide cover, where applicable, for the QA Manager.
Define, interpret and monitor key quality metrics with attention to systemic patterns and report these to the QA Manager or present to Senior leadership in the event of the QA manager’s absence
Working with other QA staff, provide support to departments and programs by reviewing reports as
necessary as well as assisting in Quality Induction and training of personnel on matters relating to the
QMS.
Support continuous improvements in the Quality Management System (QMS) and maintain compliance of Quality processes.
Support Post market surveillance and recall activities.
Maintain thorough knowledge and understanding of ISO standards requirements, regulatory
expectations, and guidance documents relevant to the work performed within the program/departments.
Use initiative to drive Quality department objectives and continuous improvement.