Lead Supplier Quality Manager, Medical Devices

BD; El Paso (TX); On-site; USD 110,000 - 160,000; Full time

Job summary

BD, a leading global medical technology company, is seeking a Supplier Quality Manager for its El Paso site. You will lead the supplier quality function, ensure purchased materials meet BD and regulatory requirements, and drive supplier performance and risk reduction across the supply chain.

You will manage a team of supplier quality engineers, partner with Operations, Procurement, Engineering, Regulatory Affairs, and Global Supplier Quality, and oversee CAPAs, supplier audits, and continuous

Qualifications

• Bachelor's degree in Engineering, Quality, Science, or a related technical field.
• Minimum 7 years of experience in Quality, Supplier Quality, or Quality Engineering in a regulated industry.
• Minimum 3 years of people leadership experience.
• Experience with supplier audits, qualification, supplier corrective actions, and supplier performance management.
• Working knowledge of FDA QMSR, ISO 13485, risk management principles, and quality system requirements.
• Strong root cause analysis, CAPA, and problem-solving skills.

Responsibilities

• Lead and develop the site Supplier Quality organization, including hiring, coaching, performance management, and talent development.
• Oversee supplier qualification, onboarding, monitoring, and requalification activities.
• Drive supplier performance improvement through quality metrics, business reviews, and risk-based assessments.
• Partner with Procurement and Global Supplier Quality on supplier selection and sourcing decisions.
• Support supplier quality agreements and quality requirements.
• Ensure effective incoming inspection and material acceptance processes.
• Monitor incoming quality trends and implement actions to reduce defects, escapes, and supplier-related nonconformances.
• Support containment activities for suspect or nonconforming materials.
• Ensure compliance with FDA QMSR, ISO 13485, applicable regulatory requirements, and BD Quality System procedures.
• Lead supplier-related investigations, CAPAs, and risk assessments.
• Ensure supplier issues are escalated, investigated, and resolved.
• Maintain inspection, supplier, and quality records in accordance with company requirements.
• Leads supplier audit planning and execution.
• Support customer, corporate, and regulatory inspections.
• Serve as the site subject matter expert for supplier quality processes and controls.
• Ensure audit observations are effectively addressed and sustained.
• Identify and execute projects that improve supplier performance, reduce cost of poor quality, and strengthen supply chain reliability.
• Utilize quality and operational excellence tools to drive measurable improvements.
• Analyze supplier quality data to identify trends, risks, and improvement opportunities.
• Lead cross-functional problem-solving efforts for significant supplier issues.
• Partner with Manufacturing, Engineering, Procurement, Regulatory Affairs, and Operations leadership to ensure supplier-related risks are effectively managed.
• Participate in change control, validation, product transfer, and new product introduction activities as required.
• Provide regular updates and performance reporting to site leadership.

Skills

Leadership

Supplier Quality

Quality Systems

Regulatory Compliance

Root Cause Analysis

Education

Bachelor's degree in Engineering/Quality/Science

Tools

SAP

TrackWise

MasterControl

Job description

BD, a leading global medical technology company, is seeking a Supplier Quality Manager for its El Paso site. You will lead the supplier quality function, ensure purchased materials meet BD and regulatory requirements, and drive supplier performance and risk reduction across the supply chain.

You will manage a team of supplier quality engineers, partner with Operations, Procurement, Engineering, Regulatory Affairs, and Global Supplier Quality, and oversee CAPAs, supplier audits, and continuous