Senior Engineer, Supplier Quality

Responsibilities

• Lead the selection, assessment, and qualification of suppliers for New Product Development (NPD) projects.
• Conduct supplier audits to ensure products conform to pre-established requirements and quality standards.
• Define supplier qualification requirements for components, devices, and custom materials.
• Develop, validate, and implement inspection and test methods to ensure regulatory compliance.
• Collaborate with manufacturing plants to optimize receiving inspection strategies and promote inspection at source.
• Utilize Six Sigma and LEAN methods to optimize complex manufacturing processes and drive continuous improvement.
• Build supplier capability and innovation through supplier excellence initiatives and onsite visits.
• Train, coach, and guide lower-level employees on complex quality procedures.

Requirements

• Bachelor’s degree in an Engineering or Scientific field with 4 years of experience in Supplier Quality, Manufacturing, NPD, or Quality Engineering.
• OR a Master’s degree in an Engineering or Scientific field with 3 years of relevant experience.
• Knowledge of FDA and international regulatory standards, specifically ISO 13485 and ISO 14971.
• Ability to travel domestically and internationally up to 25%.

Preferred Qualifications

• Experience with supplier/vendor management involving CMOs (Contract Manufacturing Organizations) or OEMs.
• Demonstrated experience in component testing, test method validations, and testing equipment.
• Experience managing CAPAs, NCRs, Change Notifications, and Auditing.
• Proficiency with design tools such as SolidWorks.
• In-depth understanding of risk management for validation qualifications (e.g., OQ/PQ).
• Ability to apply statistical quality engineering tools (e.g., Gage R&Rs, control charting, SPC).
• Certified Lead Auditor, ASQ Certified Biomedical Auditor, or Six Sigma Green/Black Belt.

About the Company

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our purpose, and we use our imagination and passion to find transformative solutions that turn dreams into possibilities across design, engineering, manufacturing, and marketing.