Director of Quality

The Director of Quality is responsible for leading the Quality Management System in compliance with ISO 13485, 21 CFR Part 820, MDSAP and other applicable regulatory requirements. This role oversees quality across the product lifecycle, including design control, operations, and post-market activities. The Director manages a team of 6 quality professionals and partners cross-functionally to ensure product quality, regulatory compliance, and continuous improvement throughout the organization.

Key Responsibilities:

• Lead implementation and oversight of design control processes for new and modified devices.
• Manage and ensure quality in operations: production, final product release, incoming inspection activities, process validation and supplier quality.
• Manage configuration and doc control process.
• Own and maintain the quality management system, including internal audits, CAPA, complaints, and management review.
• Prepare for and lead external audits (e.g. notified bodies, FDA).
• Mentor and manage a 6-person quality team to meet departmental and organizational goals.