Strategic Supplier Quality Engineer

BD; El Paso (TX); On-site; USD 100,000 - 150,000; Full time

Job summary

BD, a leading global medical technology company, seeks a Supplier Quality/Development professional in USA TX (El Paso). The role focuses on collaborating with suppliers to ensure robust materials and processes, driving root-cause analyses, and leading quality improvement projects.

Responsibilities include audits, CAPA, and change management across functions like Procurement, R&D, and Operations, with emphasis on regulatory compliance (21 CFR 820, ISO 13485, ISO 14971) and GMP environments.

Qualifications

• Bachelor’s degree in Engineering or a related field is required.
• 5 years Supplier Quality and/or Supplier Development experience.
• Understanding of 21 CFR 820, ISO 13485, and ISO 14971 requirements.
• Prior Supplier Quality experience in a manufacturing plant or technical background.
• Working experience in GMP-regulated environment preferred (medical device, pharmaceutical).
• Demonstrated knowledge of manufacturing principles and practices.

Responsibilities

• Collaborate with suppliers and business partners to ensure robust materials, products, processes, and systems.
• Support internal and supplier root cause investigations and CAPA; drive corrective actions with true root cause analysis.
• Manage and elevate supplier issues; plan, execute, report and follow-up on supplier quality system audits.
• Partner with Procurement, R&D, Engineering/Technical Operations, Quality, Operations, and Suppliers to minimize business disruptions.
• Monitor supplier performance metrics; communicate risks; drive resolution of quality issues.
• Implement supplier change management including notification, impact assessment, and qualifications.
• Own and lead supplier quality projects with limited supervision.
• Use PM/VSM, Kaizen, DMAIC, FMEA/FTA, RCA, MSA, SPC, Cp/Cpk, DOE, EVOP to support improvements.
• Comply with ISO 13485, ISO 14001 & OSHAS18001 policies.

Skills

Bilingual Spanish English

Quality engineering mindset

Education

Bachelor’s degree in Engineering or related field

Job description

BD, a leading global medical technology company, seeks a Supplier Quality/Development professional in USA TX (El Paso). The role focuses on collaborating with suppliers to ensure robust materials and processes, driving root-cause analyses, and leading quality improvement projects.

Responsibilities include audits, CAPA, and change management across functions like Procurement, R&D, and Operations, with emphasis on regulatory compliance (21 CFR 820, ISO 13485, ISO 14971) and GMP environments.