EPS Connects LLC
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.
#J-18808-Ljbffr
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.
#J-18808-Ljbffr