Quality Test Engineer — Lab Validation Lead

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

Benefits offered by this job

Annual Bonus

Potential Discretionary LTI Bonus

Potential reimbursement of phone use

Job summary

BD is seeking a Quality Test Engineer to plan, perform and lead lab validation activities that support the feasibility of new lab concepts and technologies for medical devices. You will manage product release activities, identify defects and trends, and ensure compliance with ISO, cGMP and regulatory standards.

You will work cross-functionally with Design Quality, Complaints and Release teams, maintain GLP/GDP practices, calibrate equipment, manage supplier qualifications, and uphold rigorous

Qualifications

• BS degree in Engineering, Science, or related discipline.
• Minimum 5 years of experience in a related field.
• Medical device, pharmaceutical, or diagnostic industry experience preferred.

Responsibilities

• Plans and performs equipment qualifications, test method validations, fixture development, and software validations as needed.
• Performs experimentation and develops methodologies for product testing and validation.
• Leads or contributes to nonconformance investigations, root cause analysis, and CAPA actions.
• Performs release testing or product testing, maintains documentation, and reviews inspection results.
• Supports supplier qualification activities and cross-functional collaboration with Design Quality, Complaints, and Release teams.

Skills

Technical proficiency

Cross-functional collaboration

Communication skills

Analytical problem solving

Education

BS degree in Engineering, Science, or related discipline

Tools

Software validation

Instron equipment

Job description

BD is seeking a Quality Test Engineer to plan, perform and lead lab validation activities that support the feasibility of new lab concepts and technologies for medical devices. You will manage product release activities, identify defects and trends, and ensure compliance with ISO, cGMP and regulatory standards.

You will work cross-functionally with Design Quality, Complaints and Release teams, maintain GLP/GDP practices, calibrate equipment, manage supplier qualifications, and uphold rigorous