Lead Lab Quality Engineer—Verification & Compliance

Becton Dickinson; Branchburg Township (NJ); On-site; USD 87,000 - 140,000; Full time

Benefits offered by this job

Annual Bonus Potential

Health and Well-being Benefits

Medical coverage

BD 401(k) Plan

Paid time off

Job summary

BD is seeking a Quality Engineer to lead design verification testing for combination products in compliance with FDA and ISO standards. The role collaborates across Technology Development, Operations, Quality, and Business Development to deliver compliant, validated products.

The position emphasizes GLP/GMP compliance, CAPA investigations, and strengthening QMS processes, with responsibilities including audits, data review, and mentoring engineers and lab staff.

Qualifications

• Bachelor’s degree in engineering, Biomedical Sciences, or related field with 7+ years quality engineering experience.
• Master’s degree with 5+ years experience in quality engineering.
• Experience with mechanical and analytical testing of drug-device combination products.

Responsibilities

• Lead and execute design verification testing for combination products per FDA and ISO standards.
• Develop, review, and approve test protocols and reports.
• Partner with multiple teams to drive project execution and delivery.
• Ensure GLP/GMP compliance.
• Lead CAPAs and investigations and drive continuous improvement.
• Provide mentoring and QA leadership.
• Act as QA representative during audits and inspections.
• Maintain and enhance QMS processes.
• Review project documentation before client release.
• Train employees on quality standards and investigations.

Skills

Quality engineering

Regulatory knowledge

Statistical analysis

CAPA & investigations

Technical writing

Cross-functional communication

Audits & inspections

Education

Bachelor’s degree in engineering/Biomedical Sciences

Master’s degree in engineering/ Biomedical Sciences

Tools

LIMS

Job description

BD is seeking a Quality Engineer to lead design verification testing for combination products in compliance with FDA and ISO standards. The role collaborates across Technology Development, Operations, Quality, and Business Development to deliver compliant, validated products.

The position emphasizes GLP/GMP compliance, CAPA investigations, and strengthening QMS processes, with responsibilities including audits, data review, and mentoring engineers and lab staff.