Senior Supplier Quality Engineer, NPD & Compliance

Becton Dickinson NA; Irvine (CA); Sur place; USD 130 000 - 207 000; Plein temps

Résumé du poste

BD in Irvine, CA is seeking a Senior Supplier Quality Engineer to lead supplier qualification and quality systems across New Product Development initiatives. You will drive CAPA, audits, and process validation to ensure components and materials meet design and regulatory requirements.

Join a cross-functional team that partners with manufacturing, engineering, and procurement to optimize supplier performance, implement advanced measurement methods, and mentor junior engineers.

Qualifications

• Extensive supplier qualification leadership experience.
• Expertise in supplier quality management and audits.
• Knowledge of regulatory standards (FDA/ISO 13485/14971).
• Experience with process validation and statistical methods.

Responsabilités

• Lead supplier selection, assessment, qualification and auditing for NPD.
• Define qualification strategies for components and materials.
• Implement supplier-site improvements and robust quality systems.
• Develop inspection/test methods ensuring quality and compliance.
• Lead failure investigations and root cause analysis.
• Collaborate with BD sites on receiving inspection strategies.
• Drive Lean/Six Sigma to support manufacturability and excellence.
• Maintain strategic supplier relationships and forums.
• Mentor engineers on supplier quality practices.

Connaissances

Supplier quality leadership

Component qualification

Reliability testing

CAPA & NCRs

FDA/ISO knowledge

Process validation

Gage R&R

SPC / DOE

Formation

Bachelor's degree in engineering or scientific field

Master's degree or equivalent

Ph.D. or equivalent

Outils

Gage R&R

SPC

DOE

Control charts

Sampling plans

Description du poste

BD in Irvine, CA is seeking a Senior Supplier Quality Engineer to lead supplier qualification and quality systems across New Product Development initiatives. You will drive CAPA, audits, and process validation to ensure components and materials meet design and regulatory requirements.

Join a cross-functional team that partners with manufacturing, engineering, and procurement to optimize supplier performance, implement advanced measurement methods, and mentor junior engineers.