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

• Bachelor’s degree in Engineering, Life Sciences, or related discipline (advanced degree preferred).
• 10 years of progressive experience in medical device manufacturing quality.
• Proven leadership in catheter assembly or interventional device manufacturing (balloon catheters, guidewires, introducers, etc.).
• Strong working knowledge of ISO 13485, FDA QSR, and GMP requirements.
• Demonstrated success in leading and developing cross-functional teams.
• Experience with process validation, risk management (ISO 14971), and cleanroom operations.
• Excellent communication, decision-making, and problem-solving skills.
• Willingness and ability to relocate for the right long-term opportunity.

Why This Opportunity?

• Lead quality strategy for a growing, technology-driven medical device manufacturer.
• Collaborate with innovative engineering and manufacturing teams in a hands-on, high-impact environment.
• Competitive compensation, relocation assistance, and opportunities for long-term career growth.