Job Description

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.