Position Summary 

The Supplier Quality Manager is responsible for leading the Supplier Quality function for the El Paso manufacturing site. This role ensures that purchased materials, components, and services consistently meet BD and regulatory requirements while driving supplier performance, risk reduction, and continuous improvement throughout the supply chain. 

The Supplier Quality Manager leads a team of supplier quality engineers and quality professionals responsible for supplier qualification, supplier monitoring, incoming quality activities, supplier investigations, supplier corrective actions (SCARs), supplier audits, and supplier-related risk management. This position partners closely with Operations, Procurement, Engineering, Manufacturing, Regulatory Affairs, and Global Supplier Quality to ensure uninterrupted supply of compliant product and materials. 

Key Responsibilities 

Supplier Quality Leadership 

• Lead and develop the site Supplier Quality organization, including hiring, coaching, performance management, and talent development. 

• Establish objectives, priorities, and performance metrics aligned with site and business goals. 

• Foster a culture of quality, compliance, accountability, and continuous improvement. 

Supplier Management 

• 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. 

Incoming Quality & Material Controls 

• 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. 

Quality Systems & Compliance 

• 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 appropriately escalated, investigated, and resolved. 

• Maintain inspection, supplier, and quality records in accordance with company requirements. 

Audits & Regulatory Readiness 

• Lead 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. 

Continuous Improvement 

• 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. 

Cross-Functional Collaboration 

• 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 . 

• Provide regular updates and performance reporting to site leadership. 

Qualifications 

• Bachelor's degree in Engineering, Quality, Science, or a related technical field. 

• Minimum 7 years of experience in Quality, Supplier Quality, Manufacturing Quality, or Quality Engineering within a regulated industry. 

• Minimum 3 years of people leadership experience. 

• Experience with supplier audits, supplier 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. 

• Excellent communication and stakeholder management abilities. 

Preferred 

• Medical device manufacturing experience. 

• Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), Certified Supplier Quality Professional (CSQP), Six Sigma Green Belt, or Black Belt certification. 

• Experience with SAP, TrackWise, MasterControl, or similar quality systems. 

• Experience supporting international suppliers and global supply chains. 

Leadership Competencies 

• Builds high-performing teams. 

• Drives accountability and execution. 

• Demonstrates strong business acumen and risk-based decision making. 

• Influences across functions and organizational levels. 

• Champions continuous improvement and operational excellence. 

• Maintains a patient-first and compliance-focused mindset. 

Travel 

• Up to 25% domestic and international travel to supplier sites and BD locations.