Senior Design Quality Engineer: Lead Risk & Validation

Becton Dickinson NA; Franklin Lakes (NJ); On-site; USD 110,000 - 176,000; Full time

Benefits offered by this job

Annual Bonus

Health and Well-being Benefits

Medical coverage

Health Savings Accounts

Flexible Spending Accounts

Dental coverage

Vision coverage

Hospital Care Insurance

Life and AD&D insurance

Short-term disability coverage

Long-term disability insurance

Long-term care with life insurance

Job summary

Becton Dickinson in Franklin Lakes, NJ is seeking a Quality Engineer to drive design controls, risk management, validation, supplier quality, and product release activities across R&D and Worldwide Operations. You will serve as a trusted quality advisor, proactively solve complex quality challenges, and champion continuous improvement initiatives that enhance product quality and customer experience.

The role emphasizes collaboration with cross-functional teams, audits, and robust test methods,

Qualifications

• Bachelor's Degree in relevant field and 5 years relevant experience OR Master's Degree in relevant field and 3 years relevant experience

Responsibilities

• Plan and lead Quality Engineering efforts supporting R&D and Worldwide Operations initiatives.
• Evaluate customer requirements and applicable quality standards to ensure project compliance.
• Ensure all design control requirements are effectively executed throughout product development.
• Lead product risk management activities and proactively identify, assess, and mitigate project risks.
• Ensure compliance with global product stewardship procedures, quality standards, and regulatory requirements.
• Support product release activities for products under development.
• Provide Quality Engineering guidance during audits, customer inquiries, and regulatory interactions.
• Establish and oversee worldwide validation plans for product and process designs.
• Ensure process validation activities are completed and meet quality requirements.
• Ensure supplier qualification plans affecting product design are defined and executed.
• Define and maintain global product and process control strategies.
• Establish robust incoming inspection processes, including: Test method development, Inspection criteria definition, Equipment qualification and Sustainable inspection practices.
• Ensure test methods are validated and equivalent across manufacturing sites and suppliers when applicable.
• Initiate change control submissions and collaborate with R&D and Engineering to provide quality assessments.
• Review and approve new or revised product and process specifications, including: Product performance specifications, Test methods, Process validation documentation, and Quality-related technical documentation.
• Lead or support failure investigations and root cause analysis for nonconforming products.
• Develop practical and innovative solutions to quality and product challenges.
• Ensure quality-focused project execution, including data analysis, interpretation, and reporting.
• Partner closely with Quality Operations, Integrated Supply Chain (ISC), Global Industrial Engineering (GIE), R&D, Engineering, and other cross-functional teams.
• Sserve as a trusted Quality Engineering advisor across the organization.
• Provide guidance and technical direction to junior Quality Engineers when applicable.
• Actively pursue professional development and share knowledge across teams.
• Promote continuous improvement initiatives that enhance product quality, operational effectiveness, and customer experience.
• Ensure lessons learned are captured, communicated, and leveraged across future projects.

Skills

Quality engineering

Design controls

Risk management

Regulatory compliance

Education

Bachelor's degree in relevant field

Master's degree in relevant field

Job description

Becton Dickinson in Franklin Lakes, NJ is seeking a Quality Engineer to drive design controls, risk management, validation, supplier quality, and product release activities across R&D and Worldwide Operations. You will serve as a trusted quality advisor, proactively solve complex quality challenges, and champion continuous improvement initiatives that enhance product quality and customer experience.

The role emphasizes collaboration with cross-functional teams, audits, and robust test methods,