Quality Director

Director of Quality

Location: Minnesota (Hybrid)
Industry: Medical Device

We are partnering with an innovative medical device company seeking a Director of Quality to lead quality strategy, compliance, and continuous improvement initiatives across the organization.

Responsibilities

• Lead and enhance the Quality Management System (QMS) in compliance with FDA and ISO 13485 requirements.
• Oversee CAPA, audits, supplier quality, risk management, and quality metrics.
• Partner with R&D, Operations, Regulatory Affairs, and Executive Leadership to drive quality excellence.
• Build, mentor, and develop high-performing quality teams.

Qualifications

• 10+ years of medical device quality experience with increasing leadership responsibility.
• Current or previous Quality Director, Senior Director, or Associate Director of Quality.
• Strong experience with FDA regulations, ISO 13485, CAPA, design controls, and risk management.
• Class III medical device experience strongly preferred.
• Cardiovascular, structural heart, vascular, electrophysiology, or implantable device experience highly preferred.
• Proven track record leading audits, inspections, and quality system improvements.

Why Consider This Opportunity?

• Hybrid work environment.
• High-visibility leadership role.
• Opportunity to influence quality strategy and organizational growth.
• Competitive compensation, bonus, and benefits.

Interested in learning more? Apply today for a confidential conversation.