Quality Director

Position Summary

The Director, Quality will lead Quality Systems and Quality Engineering activities for a growing medical device organization focused on developing and commercializing innovative technologies. This individual will provide leadership across design quality, manufacturing quality, supplier quality, and quality systems while ensuring compliance with FDA and international regulatory requirements. The role will partner closely with R&D, Operations, Regulatory Affairs, and Supply Chain to support product development, commercialization, and continuous improvement initiatives.

Key Responsibilities

• Lead Quality Systems, Design Quality, Manufacturing Quality, and Supplier Quality functions.
• Ensure compliance with FDA 21 CFR Part 820/QMSR, ISO 13485, EU MDR, and other applicable regulations.
• Support product development activities including Design Controls, risk management, verification/validation, and design transfer.
• Provide oversight of CAPA, nonconformances, complaint investigations, root cause analysis, and quality metrics reporting.
• Lead process validation efforts including IQ/OQ/PQ and manufacturing quality initiatives.
• Manage supplier qualification, auditing, and supplier performance programs.
• Support FDA inspections, notified body audits, and customer audits while maintaining inspection readiness.
• Establish quality objectives and drive continuous improvement initiatives across the organization.
• Build and develop a high-performing quality team while fostering a culture of compliance and quality excellence.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or related technical field.
• 10+ years of quality experience within the medical device industry.
• 5+ years of leadership experience managing quality teams.
• Strong knowledge of Design Controls, CAPA, Risk Management (ISO 14971), Process Validation, and Quality Systems.
• Experience supporting FDA inspections and ISO 13485-certified environments.
• Demonstrated success partnering with R&D and Operations teams to bring products from development through commercialization.
• Experience with Class II and/or Class III medical devices preferred.

Preferred Background

• Cardiovascular, structural heart, electrophysiology, robotics, neurovascular, or minimally invasive medical device experience.
• ASQ certifications (CQE, CQA, CMQ/OE) and/or Lean Six Sigma certification preferred.
• Experience supporting new product introductions, scale-up manufacturing, and global quality initiatives.

Ideal Candidate: A hands-on quality leader capable of balancing strategic quality system ownership with day-to-day operational support in a fast-paced, growth-stage medtech environment.