Senior Design Quality Engineer - MedTech Impact

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

Benefits offered by this job

Annual Bonus

Potential Discretionary LTI Bonus

Job summary

BD, a global medical technology leader based in Franklin Lakes, NJ, is seeking a Quality Engineer to drive design controls, risk management, validation and supplier quality across development and manufacturing.

You will partner with cross-functional teams, lead audits and change controls, and champion continuous improvement to ensure high-quality products and customer satisfaction in a fast-paced healthcare environment.

Qualifications

• Bachelor's degree required with 5 years of relevant experience or Master's degree with 3 years of 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.
• 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, a global medical technology leader based in Franklin Lakes, NJ, is seeking a Quality Engineer to drive design controls, risk management, validation and supplier quality across development and manufacturing.

You will partner with cross-functional teams, lead audits and change controls, and champion continuous improvement to ensure high-quality products and customer satisfaction in a fast-paced healthcare environment.