Quality Manager

The Quality Manager works to deliver consistent quality of performance through the management of an effective Quality Management System, promotes a strong Quality culture within the business, and develops, through coaching and mentorship, the skills and experience of the Quality team.

ESSENTIAL DUTIES AND RESPONSIBILITIES

Acts as the Management representative for the site and is responsible for the overall effectiveness of the site QMS processes in line with the requirement of 13485:2016. Manage customer complaints process, non-conforming material process and CAPA (Corrective and Preventive Action) implementation, and associated follow-up activities. Develop, review, and approve QA documentation as related to general QA activities required within the site. Report on QMS performance to top management and recommend improvements based on trends and analysis of process performance. Develop strong customer relationships through professional, constructive, proactive communication on product, process and system quality requirements including change notifications and responsiveness to quality concerns. Ensure all manufacturing processes are verified or validated, monitored, and maintained in and maintained in line with customer requirements, FDA 21 CFR 820, ISO 13485, and other applicable regulations. Lead internal and external audit programs, including notified body inspections. Build, mentor, and lead a high-performing Quality team, support their professional development and ensure alignment within the team against business objectives. Champion a Quality culture of Customer focus, proactively identifying and implementing process improvements and quality best practices across the business Manages the Quality budget and works with site management to deliver business objectives.