Director of Quality

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, high-mix 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.

Seniority level

• Mid-Senior level

Employment type

• Full-time

Job function

• Project Management, Product Management, and Quality Assurance
• Industries: Medical Equipment Manufacturing and Plastics Manufacturing

Ohio, United States base posted compensation details and related job postings are for reference only.