EPS Connects LLC · 1 day ago
Director of Quality
Jeffersonville, IN
Full-time
Onsite
Director/Executive
10+ years expEPS Connects LLC is a growing, technology-driven medical device manufacturer seeking a Manufacturing Quality Director. The role involves providing strategic leadership across manufacturing quality functions, ensuring product integrity and regulatory compliance, while overseeing in-process quality, validation, and continuous improvement in a catheter assembly environment.
Staffing & Recruiting
Hiring Manager
Eric Sandberg
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
Qualification
Required
Bachelor's degree in Engineering, Life Sciences, or related discipline
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
Preferred
advanced degree
Willingness and ability to relocate for the right long-term opportunity
Benefits
Competitive compensation
Relocation assistance
Opportunities for long-term career growth
Company
EPS Connects LLC
EPS Connects specializes in executive and technical search across injection molding, metalworking, and extrusion.
2-10 employees
Funding
Current Stage
Early StageLeadership Team
Eric Sandberg
President/Founder
Company data provided by crunchbase