Director of Quality

Position Overview

The Manufacturing Quality Director will provide strategic and hands-on leadership across all manufacturing quality functions, ensuring product integrity, regulatory compliance, and operational excellence in a fast-paced, catheter assembly medical device environment.

This role oversees all aspects of in-process quality, validation, supplier quality, and continuous improvement , with a specific emphasis on catheter assembly and complex subassemblies for medical device applications.

The ideal candidate brings a deep understanding of ISO 13485, FDA QSR, and GMP requirements , paired with the ability to lead teams, partner with engineering and operations, and elevate quality systems across multiple sites.

Key Responsibilities

• Lead the Manufacturing Quality organization (inspection, in-process control, validation, CAPA, and supplier quality).
• Oversee process validation (IQ / OQ / PQ) and ensure compliant, risk-based approaches to manufacturing changes.
• Provide technical and strategic guidance for catheter assembly processes , including bonding, molding, extrusion, and testing.
• Partner with Operations and Engineering to drive Design for Manufacturability (DFM) and Design for Quality (DFQ) .
• Develop and implement KPIs and quality metrics for performance visibility and continuous improvement.
• Manage regulatory compliance with FDA 21 CFR Part 820, ISO 13485, and applicable global requirements.
• Serve as the primary point of contact during customer audits, FDA inspections, and Notified Body reviews .
• Lead root cause analysis, CAPA, and nonconformance management across product lines.
• Champion a culture of proactive quality and operational excellence.
• Support company-wide initiatives around Lean, Six Sigma, and digital quality systems integration.

Qualifications

Why This Opportunity?