Fixed-Term Supplier Quality Engineer - Quality & Compliance

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

Job summary

BD in Tempe, AZ seeks a Supplier Quality Engineer on a fixed-term assignment through 10/31/2027. You will develop and maintain supplier quality systems, conduct audits, and lead CAPA with internal teams and suppliers to improve product quality and reduce costs.

Responsibilities include overseeing supplier quality documentation, supplier qualification, and collaboration with R&D, Sourcing, Manufacturing, and Regulatory Affairs to ensure compliance with ISO 13485 and FDA QSR.

Qualifications

• Bachelor's degree in Engineering or related technical field is required.
• Minimum 3–5 years in supplier quality engineering or similar in a regulated industry (medical devices preferred).
• Strong understanding of ISO 13485 and 21 CFR Part 820 requirements.
• Experience with quality tools: FMEA, SPC, MSA, 8D and root cause analysis.
• Experience conducting supplier audits and assessments.
• Excellent analytical, problem-solving, and decision-making skills.
• Strong communication and interpersonal skills; able to collaborate with internal teams and suppliers.
• ASQ CQE or CQA certifications are a plus.

Responsibilities

• Develop, implement, and maintain supplier quality management systems and procedures per regulations.
• Conduct supplier audits and assessments of quality systems and processes.
• Lead selection and qualification of new suppliers and review specs, quality plans, and validations.
• Monitor supplier performance metrics, identify trends, and drive CAPA.
• Collaborate with R&D, Sourcing, Manufacturing, and Regulatory Affairs to define CTQ characteristics.
• Manage supplier-related quality issues, including disposition and root-cause verification.
• Drive continuous improvement projects with suppliers to improve quality and reduce costs.
• Prepare and present reports on supplier quality performance and risks.

Skills

Analytical skills

Problem-solving

Communication skills

Interpersonal skills

Decision-making

Team collaboration

Regulatory knowledge

Education

Bachelor's degree in Engineering

Tools

FMEA

SPC

MSA

8D problem solving

Job description

BD in Tempe, AZ seeks a Supplier Quality Engineer on a fixed-term assignment through 10/31/2027. You will develop and maintain supplier quality systems, conduct audits, and lead CAPA with internal teams and suppliers to improve product quality and reduce costs.

Responsibilities include overseeing supplier quality documentation, supplier qualification, and collaboration with R&D, Sourcing, Manufacturing, and Regulatory Affairs to ensure compliance with ISO 13485 and FDA QSR.