Director of Quality

EPS Connects LLC; Kentucky; On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Competitive compensation

Relocation assistance

Opportunities for long-term career growth

Job summary

A growing technology-driven medical device manufacturer is seeking a Manufacturing Quality Director with extensive experience in overseeing quality functions and ensuring regulatory compliance. This role will lead initiatives in catheter assembly processes and drive quality improvements across the organization. The ideal candidate should have a deep understanding of ISO 13485 and FDA regulations, along with strong leadership skills to develop cross-functional teams.

Qualifications

• 10+ years of progressive experience in medical device manufacturing quality.
• Proven leadership in catheter assembly or interventional device manufacturing.
• Experience with process validation and cleanroom operations.

Responsibilities

• Lead the Manufacturing Quality organization.
• Oversee process validation and ensure compliance.
• Provide guidance for catheter assembly processes.

Skills

Leadership in quality management

Knowledge of ISO 13485

Strong communication skills

Problem-solving skills

Education

Bachelor’s degree in Engineering or Life Sciences

Advanced degree preferred

Job description

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.