Director, Quality

This role provides strategic quality leadership for manufacturing sites, ensuring compliance with global regulatory standards like 21 CFR 820 and ISO 13485 while driving a culture of quality and innovation. As the management representative accountable for the local Quality Management System, the individual will lead high-performing teams, manage customer relationships, and oversee design assurance and new product introduction processes. The position requires deep expertise in statistical concepts, root cause analysis, and continuous improvement methodologies within a regulated medical device environment.