Director of Quality

Location: Minneapolis Metro, MN (On-site)

The Opportunity

A growing medical device company is looking for a Director of Quality to lead its Quality Management System and Product Quality functions. Reporting into executive leadership, you'll drive quality strategy, regulatory compliance, and continuous improvement across the full product lifecycle.

Key Responsibilities

• Lead and improve the Quality Management System (QMS).
• Oversee Design Assurance, Manufacturing Quality, Supplier Quality, CAPA, Complaints, and Post-Market activities.
• Ensure compliance with FDA, ISO 13485, ISO 14971, and global quality standards.
• Lead FDA, customer, supplier, and certification audits.
• Partner cross-functionally with Engineering, Operations, and Regulatory teams.
• Build, mentor, and develop a high-performing Quality team.

What We're Looking For

• 10+ years' Quality experience within medical devices.
• Leadership experience managing Quality teams.
• Strong knowledge of FDA 21 CFR Part 820, ISO 13485, and ISO 14971.
• Experience across Design Assurance, Supplier Quality, Manufacturing Quality, CAPA, and audits.
• A hands-on leader with a continuous improvement mindset.