Quality Test Engineer — Lab Validation & Compliance

Regulatory Jobs; Franklin Lakes (NJ); On-site; USD 87,000 - 140,000; Full time

Benefits offered by this job

Annual bonus

Health and well-being benefits

401(k) plan

Job summary

BD is seeking a Quality Test Engineer to lead lab validation activities supporting new and improved lab concepts and technologies. Responsibilities include equipment qualifications, test method validations, and data analysis to ensure product robustness and regulatory compliance.

The role involves cross-functional collaboration, investigation of root causes, and ensuring documentation and release testing meet ISO, cGMP, and related standards.

Qualifications

• BS degree in Engineering, Science, or related discipline.
• Minimum 5 years experience or equivalent education.
• Experience in medical device, pharmaceutical, or diagnostic industries preferred.

Responsibilities

• Plan and perform equipment qualifications, test method validations, and software validations.
• Lead or contribute to nonconformance investigations and CAPAs.
• Perform release and product testing with proper documentation and trend analysis.
• Assist with supplier qualification and maintain GLP/GDP documentation.
• Support audits and ensure ISO, FDA, OSHA, ASTM compliance.

Skills

Lab instrumentation

Software validation

Root cause analysis

Document control

Cross-functional teamwork

Education

BS in Engineering/Science

Tools

Instron

Validation software

Job description

BD is seeking a Quality Test Engineer to lead lab validation activities supporting new and improved lab concepts and technologies. Responsibilities include equipment qualifications, test method validations, and data analysis to ensure product robustness and regulatory compliance.

The role involves cross-functional collaboration, investigation of root causes, and ensuring documentation and release testing meet ISO, cGMP, and related standards.