Senior Supplier Quality Engineer – NPD & Process Excellence

Becton Dickinson; Irvine (CA); On-site; USD 130,000 - 207,000; Full time

Job summary

BD in Irvine is seeking a senior supplier quality engineer to lead qualification, auditing, and development with a strong emphasis on regulatory compliance and process improvement. You will shape supplier quality strategies for components and materials across NPD programs.

You will drive CAPA, risk management, and advanced measurement methodologies, mentoring engineers and collaborating with cross‑functional teams to meet quality and business objectives.

Qualifications

• Experience leading supplier qualification and quality initiatives.
• Strong knowledge of FDA regulations, ISO 13485, ISO 14971 in medical devices.
• Proven ability to mentor engineers and drive cross‑functional projects.

Responsibilities

• Lead supplier qualification and auditing for NPD projects.
• Define qualification strategies for components and materials.
• Drive continuous improvement via Lean and Six Sigma.
• Lead failure investigations and root cause analysis.
• Develop inspection and test methods to ensure regulatory compliance.

Skills

Supplier qualification

Supplier quality management

Supplier development

CAPA/NCRs

Risk management

FDA regulations

ISO 13485/14971

Six Sigma

SPC / Gage R&R

Leadership / cross-functional

Education

Bachelor’s degree in engineering or scientific field

Master’s degree in engineering or scientific field

Ph.D. in engineering or scientific field

Tools

Gage R&R

SPC

DOE

Control charts

Process validation

IQ/OQ/PQ validation

Medical device QA systems

Job description

BD in Irvine is seeking a senior supplier quality engineer to lead qualification, auditing, and development with a strong emphasis on regulatory compliance and process improvement. You will shape supplier quality strategies for components and materials across NPD programs.

You will drive CAPA, risk management, and advanced measurement methodologies, mentoring engineers and collaborating with cross‑functional teams to meet quality and business objectives.