Our client is an innovative Class III medical device company developing and manufacturing life-sustaining and implantable technologies that improve patient outcomes worldwide. We are seeking a Director of Quality to lead quality strategy, quality systems, and manufacturing quality across product development and commercial operations.

Position Summary

The Director of Quality will provide strategic and operational leadership for the Quality organization, ensuring compliance with FDA, ISO 13485, and global regulatory requirements while supporting product development, manufacturing, supplier quality, and post-market activities. This individual will serve as a key member of the leadership team, driving a culture of quality, continuous improvement, and regulatory excellence.

Key Responsibilities

• Lead and evolve the Quality Management System (QMS) to ensure compliance with FDA 21 CFR Part 820, ISO 13485, MDR, and other applicable regulations.
• Provide quality leadership across product development, design transfer, validation, manufacturing, supplier management, and post-market surveillance activities.
• Oversee CAPA, nonconformance, complaint handling, audit readiness, change control, and risk management processes.
• Partner with R&D, Manufacturing, Regulatory Affairs, Supply Chain, and Clinical teams to support new product introductions and commercial operations.
• Ensure robust risk management practices, including DFMEA, PFMEA, hazard analysis, and ongoing risk assessments.
• Lead internal, supplier, customer, and regulatory inspections and audits.
• Drive continuous improvement initiatives utilizing Lean, Six Sigma, and data-driven quality methodologies.
• Manage quality metrics and present performance trends, risks, and strategic initiatives to executive leadership.
• Develop and mentor a high-performing Quality organization, including Quality Engineering, Supplier Quality, and Quality Systems teams.
• Support inspection readiness and serve as a primary quality contact during FDA, notified body, and customer audits.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or related technical field; advanced degree preferred.
• 10+ years of progressive Quality experience within the medical device industry.
• Demonstrated leadership experience managing Quality teams in a Class III medical device environment.
• Strong working knowledge of FDA Quality System Regulation, ISO 13485, risk management, and design controls.
• Experience supporting product development through commercialization and sustaining manufacturing.
• Proven success leading CAPA, root cause investigations, quality system improvements, and regulatory inspections.
• Experience with implantable, cardiovascular, structural heart, neuromodulation, electrophysiology, vascular, or other highly regulated Class III products is strongly preferred.
• ASQ certifications (CQE, CQA, CMQ/OE) are a plus.

Preferred Background

• Experience in both development and manufacturing quality organizations.
• Successful FDA inspection and notified body audit leadership experience.
• Expertise in process validation (IQ/OQ/PQ), supplier quality management, statistical analysis, and risk management.
• Strong executive presence with the ability to influence across all levels of the organization.

Why Join?

• Opportunity to impact innovative Class III technologies that improve and save lives.
• High visibility leadership position with direct influence on company strategy.
• Collaborative executive team and strong growth trajectory.
• Competitive compensation package including bonus, equity, and comprehensive benefits.