Director/Senior Director, Product Quality

We are hiring a Director / Senior Director of Product Quality to lead lifecycle quality strategy and process transformation initiatives across a complex regulated product portfolio. This role oversees Quality Engineering and Quality Control functions supporting inspection, sustaining activities, validation, and CAPA execution. This leader will drive enterprise product quality improvements, implement Six Sigma methodologies, and strengthen validation and CAPA maturity across the organization.

Responsibilities

• Lead Quality Engineering and Quality Control organizations
• Oversee incoming inspection, final QC inspection, and sustaining quality support
• Drive process transformation initiatives across validation and CAPA systems
• Support design changes and lifecycle product quality strategy
• Implement Six Sigma tools to improve operational effectiveness
• Partner with cross-functional stakeholders across Operations, R&D, and Regulatory
• Strengthen inspection readiness and compliance posture
• Mentor managers and develop technical quality leadership capability

Requirements

• 15–20+ years experience in regulated medical device or IVD environments
• Certified Quality Engineer (CQE) required
• Six Sigma Black Belt required
• Deep expertise in CAPA and process validation
• Experience managing large technical teams (30-40+) in inspection or QC environments
• Strong background supporting lifecycle product quality
• Familiarity with GD&T and mechanical inspection preferred
• IVD experience preferred (medical device acceptable)
• Proven experience leading Quality through Change & Transformation

Work Environment

• Primarily onsite leadership role (4X per week)

Compensation

• Base salary $180-240k + bonus