Contract: Supplier Quality Engineer (Medical Devices)

Becton Dickinson NA; Tempe (AZ); Presencial; USD 85.000 - 120.000; Jornada completa

Descripción de la vacante

BD, a leading global medical technology company, is seeking a Supplier Quality Engineer for a fixed-term assignment in Tempe, AZ. You will drive supplier quality programs, audits, and CAPA processes to ensure compliant, high-quality components for BD products.

The role requires 3–5 years in supplier quality within regulated industries, strong knowledge of ISO 13485 and 21 CFR Part 820, and experience with FMEA, SPC, MSA, and 8D problem-solving.

Formación

• Bachelor’s degree in Engineering (e.g., Mechanical, Biomedical, Electrical, Industrial) or a related technical field.
• Minimum of 3–5 years of experience in supplier quality engineering, quality assurance, or a similar role within a regulated industry, preferably medical devices.
• Strong understanding of quality management systems (e.g., ISO 13485, 21 CFR Part 820) and associated regulatory requirements.
• Proficiency in quality tools and methodologies such as FMEA, SPC, MSA, 8D problem-solving, and root cause analysis.
• Experience conducting supplier audits and assessments.

Responsabilidades

• Develop, implement, and maintain supplier quality management systems and procedures to ensure compliance with internal and external regulations (e.g., ISO 13485, FDA QSR).
• Conduct supplier audits and assessments to evaluate their quality systems, manufacturing processes, and overall capability to meet BD's specifications and quality requirements.
• Lead and participate in the selection and qualification of new suppliers, including the review of technical specifications, quality plans, and process validations.
• Monitor supplier performance metrics, identify trends, and implement corrective and preventive actions (CAPA) to address quality non-conformances and improve supplier performance.
• Collaborate with R&D, Sourcing, Manufacturing, and Regulatory Affairs teams to define critical-to-quality characteristics for new products and ensure supplier readiness.
• Manage and resolve supplier-related quality issues, including non-conforming material disposition, root cause analysis, and effectiveness verification of corrective actions.
• Drive continuous improvement projects with suppliers to enhance product quality, reduce costs, and optimize supply chain efficiency.
• Prepare and present regular reports on supplier quality performance, risks, and improvement initiatives to management.
• Ensure all supplier quality documentation is accurate, complete, and maintained in accordance with company policies and regulatory requirements.

Conocimientos

Quality systems knowledge

Supplier audits

Analytical problem solving

Communication skills

Regulatory compliance

Educación

Bachelor's degree in Engineering

Herramientas

FMEA

SPC

MSA

8D

Root Cause Analysis

Descripción del empleo

BD, a leading global medical technology company, is seeking a Supplier Quality Engineer for a fixed-term assignment in Tempe, AZ. You will drive supplier quality programs, audits, and CAPA processes to ensure compliant, high-quality components for BD products.

The role requires 3–5 years in supplier quality within regulated industries, strong knowledge of ISO 13485 and 21 CFR Part 820, and experience with FMEA, SPC, MSA, and 8D problem-solving.