Senior Design Quality Engineer: Lead Risk & Validation

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

Benefits offered by this job

Annual Bonus

Discretionary LTI Bonus

Medical coverage

Dental coverage

Vision coverage

Life and AD&D insurance

Job summary

BD in Franklin Lakes, NJ is seeking a Quality Engineer to drive design controls, risk management, validation, supplier quality, and product release activities across cross-functional teams.

The role focuses on acting as a trusted quality advisor, leading investigations, defining validation plans, and supporting audits to ensure regulatory compliance and high product quality. Salary range $110,200.00 – $176,400.00 USD annually; on-site work and benefits are included.

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.
• Serve 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.

Education

Bachelor’s Degree in relevant field

Master’s Degree in relevant field

Job description

BD in Franklin Lakes, NJ is seeking a Quality Engineer to drive design controls, risk management, validation, supplier quality, and product release activities across cross-functional teams.

The role focuses on acting as a trusted quality advisor, leading investigations, defining validation plans, and supporting audits to ensure regulatory compliance and high product quality. Salary range $110,200.00 – $176,400.00 USD annually; on-site work and benefits are included.