Strategic Supplier Quality Engineer (Medical Devices)

BD; Tempe (AZ); On-site; USD 90,000 - 120,000; Full time

Job summary

BD in Tempe, AZ is seeking a Supplier Quality Engineer on a fixed-term assignment through 10/31/27. You will develop and maintain supplier quality management systems, conduct supplier audits, and manage supplier qualification to meet ISO 13485 and 21 CFR Part 820.

Collaborate with R&D, Sourcing, Manufacturing and Regulatory Affairs to define CTQ characteristics, drive CAPA, monitor performance, and drive cost-down initiatives while ensuring quality.

Qualifications

• Bachelor's degree in Engineering or related technical field.
• 3–5 years in supplier quality in regulated industries.
• Knowledge of ISO 13485 and 21 CFR Part 820.
• ASQ CQE/CQA is a plus.

Responsibilities

• Develop, implement, and maintain supplier quality management systems and procedures.
• Conduct supplier audits and assessments to evaluate quality systems and capabilities.
• Lead and participate in supplier qualification activities and review of technical specs and process validations.
• Monitor supplier performance metrics and implement CAPA to address non-conformances.
• Collaborate with R&D, Sourcing, Manufacturing, and Regulatory teams to define CTQ characteristics.
• Manage and resolve supplier-related quality issues including disposition and root-cause analysis.
• Drive continuous improvement projects with suppliers to reduce costs and improve quality.
• Prepare and present reports on supplier quality performance and risks.

Skills

Analytical thinking

Communication skills

Problem solving

Team collaboration

Education

Bachelor's degree in Engineering

Tools

FMEA

SPC

MSA

8D

Root cause analysis

Job description

BD in Tempe, AZ is seeking a Supplier Quality Engineer on a fixed-term assignment through 10/31/27. You will develop and maintain supplier quality management systems, conduct supplier audits, and manage supplier qualification to meet ISO 13485 and 21 CFR Part 820.

Collaborate with R&D, Sourcing, Manufacturing and Regulatory Affairs to define CTQ characteristics, drive CAPA, monitor performance, and drive cost-down initiatives while ensuring quality.