Senior Design Quality Engineer - Lead RCA & Validation

BD; Franklin Lakes (NJ); On-site; USD 110,200 - 176,400; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

Paid time off

Employee Assistance Program

Wellness programs

Job summary

BD is seeking a Quality Engineer to lead failure investigations, review design and process specs, and drive quality programs across manufacturing sites. You will independently analyze complex quality and processing challenges and guide teams to robust, compliant solutions.

The role focuses on design controls, risk management, process validation, and ongoing improvements to ensure product quality and regulatory alignment. On-site presence is emphasized in a fast-paced healthcare environment.

Qualifications

• Thorough understanding of industry regulations/standards: ISO 13485, QSR, GMP; design control principles.
• Strong grasp of statistical methods for QA and Six Sigma process methodologies.
• Experience with Quality System, Six Sigma, Validation, FMEA/Risk Management; knowledge of manufacturing.

Responsibilities

• Lead and support failure investigations and root cause analyses for non-conforming products.
• Review and approve design/process specifications, performance requirements, test methods, and validation docs.
• Drive quality programs, projects, and continuous improvement with cross-functional teams.

Skills

Regulatory knowledge

Statistics & Six Sigma

Quality systems & validation

Problem solving

Project management

Clear communication

Education

BS in Engineering or related field

MS in Engineering or related field

Job description

BD is seeking a Quality Engineer to lead failure investigations, review design and process specs, and drive quality programs across manufacturing sites. You will independently analyze complex quality and processing challenges and guide teams to robust, compliant solutions.

The role focuses on design controls, risk management, process validation, and ongoing improvements to ensure product quality and regulatory alignment. On-site presence is emphasized in a fast-paced healthcare environment.