Vice President, Quality

Position Summary

The Vice President, Quality will provide executive leadership for the company's Quality organization and Quality Management System (QMS), ensuring alignment with corporate objectives, regulatory requirements, and commercial growth initiatives. This individual will oversee Quality Systems, Design Quality, Manufacturing Quality, Supplier Quality, and Post-Market Quality functions while serving as a key member of the executive leadership team.

The VP of Quality will play a critical role in supporting product development, commercialization, manufacturing scale-up, and regulatory compliance for Class II and Class III medical devices.

Key Responsibilities

• Establish and execute the company's overall quality strategy and quality objectives.
• Lead Quality Systems, Design Assurance, Manufacturing Quality, Supplier Quality, and Quality Engineering organizations.
• Ensure compliance with FDA QMSR (21 CFR Part 820), ISO 13485, ISO 14971, MDSAP, EU MDR, and other applicable global regulations.
• Provide executive oversight of Design Controls, risk management, verification and validation, design transfer, and product lifecycle quality activities.
• Lead company-wide CAPA, nonconformance, complaint handling, audit, and inspection readiness programs.
• Partner with R&D, Operations, Regulatory Affairs, Clinical, and Supply Chain leadership to support product development and commercialization.
• Drive quality metrics, management reviews, and continuous improvement initiatives across the organization.
• Lead FDA inspections, notified body audits, customer audits, and regulatory interactions.
• Develop and mentor quality leadership teams while fostering a culture of quality, compliance, and accountability.
• Serve as a key advisor to executive leadership on quality, compliance, operational risk, and product performance.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or related technical discipline; advanced degree preferred.
• 15+ years of progressive medical device quality experience with 8+ years of leadership experience.
• Demonstrated leadership of multi-functional quality organizations within Class II and/or Class III medical device environments.
• Deep expertise in Quality Systems, Design Controls, CAPA, Risk Management, Supplier Quality, Process Validation, and Manufacturing Quality.
• Proven experience leading FDA inspections, ISO 13485 audits, MDSAP audits, and regulatory remediation activities.
• Strong executive presence with experience partnering directly with senior leadership and board-level stakeholders.

Preferred Background

• Structural Heart, Cardiovascular, Electrophysiology, Neuromodulation, Peripheral Vascular, or other implantable medical device experience.
• Experience supporting products through development, clinical studies, PMA approval, and commercial manufacturing.
• ASQ certifications (CQE, CQA, CMQ/OE) and Lean Six Sigma credentials preferred.