Lead Design Quality Engineer: Risk, Validation & Release

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

Benefits offered by this job

Annual Bonus Potential

Discretionary LTI Bonus

Health and Well-being Benefits

Medical coverage

Health Savings Accounts

Flexible Spending Accounts

Dental coverage

Vision coverage

Hospital Care Insurance

Critical Illness Insurance

Life and AD&D insurance

Short-term disability coverage

Long-term disability insurance

Long-term care with life insurance

Employee Assistance Program (EAP)

Paid Parental Leave

Job summary

BD (Becton, Dickinson and Company) seeks an experienced Quality Engineer to drive design controls, risk management, and validation activities across R&D and Worldwide Operations. You will partner with cross-functional teams to ensure compliance with quality standards and regulatory requirements, supporting product release and audits.

The role emphasizes robust supplier qualification, process validation, and continuous improvement to enhance product quality and customer experience.

Qualifications

• Bachelor's Degree in relevant field with 5+ years of related experience or Master's Degree with 3+ years of related experience.
• Experience designing controls, risk management, validation, supplier quality, and product release activities is essential.
• Willingness to work on-site and collaborate across cross-functional teams in a regulated environment.

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.
• Define and maintain global product and process control strategies.
• Establish robust incoming inspection processes, including test method development and equipment qualification.
• 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 and related documentation.
• Lead or support failure investigations and root cause analysis for nonconforming products.
• Develop practical and innovative solutions to quality and product challenges.
• Promote continuous improvement initiatives that enhance product quality and customer experience.

Skills

Quality Engineering

Design controls

Risk management

Regulatory compliance

Validation

Audit support

Education

Bachelor's Degree in relevant field

Master's Degree in relevant field

Tools

CAPA systems

Statistical software

Job description

BD (Becton, Dickinson and Company) seeks an experienced Quality Engineer to drive design controls, risk management, and validation activities across R&D and Worldwide Operations. You will partner with cross-functional teams to ensure compliance with quality standards and regulatory requirements, supporting product release and audits.

The role emphasizes robust supplier qualification, process validation, and continuous improvement to enhance product quality and customer experience.