Lab Quality Engineer - Verification & Compliance Lead

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

Benefits offered by this job

Annual Bonus

Discretionary LTI Bonus

Job summary

BD is a leading global medical technology company. This role focuses on leading design verification testing for combination products, ensuring compliance with FDA, ISO, and GMP standards, and driving continuous quality improvements across laboratories and manufacturing environments.

The position emphasizes collaboration with Technology Development, Operations, Quality, and Business Development teams, mentoring engineers, and acting as QA representative during audits and inspections.

Qualifications

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

Responsibilities

• Lead and execute design verification testing for combination products per FDA 21 CFR Parts 210, 211, 820 and ISO 13485.
• Develop, review, and approve test protocols, methods, and reports ensuring alignment with design control, risk management, and regulatory needs.
• Partner with cross-functional teams to drive project execution and delivery.
• Ensure laboratory operations comply with GLP and GMP standards.
• Lead root cause investigations, CAPAs, deviations, nonconformances, and OOS/OOT events.

Skills

Design verification testing

Quality Assurance

Regulatory compliance

Statistical analysis

Technical leadership

Education

Bachelor's degree in engineering or Biomedical Sciences

Master's degree in engineering or Biomedical Sciences

Tools

LIMS

Job description

BD is a leading global medical technology company. This role focuses on leading design verification testing for combination products, ensuring compliance with FDA, ISO, and GMP standards, and driving continuous quality improvements across laboratories and manufacturing environments.

The position emphasizes collaboration with Technology Development, Operations, Quality, and Business Development teams, mentoring engineers, and acting as QA representative during audits and inspections.