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.
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