Senior Supplier Quality Engineer – NPD & Compliance

bdx; Irvine (CA); On-site; USD 106,000 - 169,000; Full time

Job summary

BD, a global medical technology leader, seeks a supplier quality/engineering professional in Irvine to lead supplier qualification for NPD, define qualification requirements, and drive inspection method development to assure product quality and regulatory compliance.

You will collaborate with BD plants to optimize receiving inspection and manufacturing processes, while applying Six Sigma and LEAN methods to design for manufacturing and continuous improvement.

Qualifications

• Bachelor’s degree in Engineering or Scientific field with 4 years of experience in either Supplier Quality, Manufacturing, New Product Development/Improvement, or Quality engineering functions; OR a Master’s degree in Engineering or Scientific field with 3 years of experience in either Supplier Quality, Manufacturing, New Product Development/Improvement, or Quality engineering functions.
• Experience with supplier/vendor management and qualification activities with new suppliers, CMOs or OEMs for new products.
• Demonstrated experience driving component testing, test method validations, and testing equipment.
• Experience with CAPAs, NCRs, Change Notifications, and/or Auditing.
• Utilizing design tools such as SolidWorks (or other similar design tools).
• Knowledge of FDA and ISO 13485/14971 standards for medical devices is preferred.

Responsibilities

• Be a trusted partner by leading the selection, assessment, and qualification of suppliers for NPD projects including supplier audits to ensure products conform to requirements.
• Drive excellence by defining supplier qualification requirements for components, devices and custom materials for NPD projects to ensure R&D and Manufacturability balance.
• Lead the development, validation, and implementation of inspection and test methods to ensure product quality and regulatory/internal requirements compliance.
• Foster collaboration with BD plants to establish an optimized receiving inspection strategy while promoting inspection at source.
• Lead efforts to optimize complex Manufacturing processes using SIX Sigma and LEAN for design for manufacturing and continuous improvement.
• Build supplier capability and innovation through BD’s supplier excellence initiatives; identify and implement improvements in products and processes at suppliers.
• Build strong supplier relationships through onsite visits, BD’s supplier relationship management programs, supplier forums and other interactions.
• Train, coach, and guide lower-level employees on more complex procedures

Skills

Supplier Quality

Manufacturing

New Product Development/Improvement

Quality Engineering

Education

Bachelor’s degree in Engineering or Scientific field

Master’s degree in Engineering or Scientific field

Tools

SolidWorks

Job description

BD, a global medical technology leader, seeks a supplier quality/engineering professional in Irvine to lead supplier qualification for NPD, define qualification requirements, and drive inspection method development to assure product quality and regulatory compliance.

You will collaborate with BD plants to optimize receiving inspection and manufacturing processes, while applying Six Sigma and LEAN methods to design for manufacturing and continuous improvement.