MedTech Quality Engineer: Validation & CAPA Leader

Becton, Dickinson and Company; Delran Township (NJ); On-site; USD 84,000 - 134,000; Full time

Benefits offered by this job

Annual Bonus Potential

Health and Well-being Benefits

Medical coverage

BD 401(k) Plan

Vision coverage

Life and AD&D insurance

Paid time off

Job summary

BD Delran plant is seeking a Quality Engineer to author, review, and approve QMS documents supporting quality objectives. You will lead validation activities, investigate nonconformances, and drive CAPAs across projects, ensuring compliance with FDA QSR and ISO13485.

Responsibilities include reviewing records, calibrations, and coordinating audits while collaborating with suppliers and cross-functional teams to maintain manufacturing quality and continuous improvement.

Qualifications

• Bachelor's degree in Biomedical/Engineering or related field.
• 3 years experience in medical devices/manufacturing in a Quality Engineering role.
• Knowledge of FDA QSR and ISO13485.
• Good written and oral communication.

Responsibilities

• Lead validation activities and protocols for new product development and process changes.
• Provide technical and quality engineering support for manufacturing projects.
• Investigate quality issues and manage NCRs with MRB involvement.
• Develop and maintain quality documentation and inspection procedures.
• Coordinate calibration of measuring and monitoring equipment.
• Participate in audits and regulatory inspections.
• Review Lot History Records for accuracy and regulatory compliance.
• Review and approve customer specifications and product requirements.
• Investigate customer complaints, determine root causes, and support corrective actions and preventive actions (CAPAs).
• Coordinate calibration activities for measuring equipment to maintain accuracy.
• Participate in audits and regulatory inspections to support ongoing compliance and continuous improvement.

Skills

Quality engineering

Problem solving

Communication skills

Multi-tasking

Project planning

People management

Education

BS in Biomedical/Engineering

Tools

Minitab

MS Excel

Statistical software

Job description

BD Delran plant is seeking a Quality Engineer to author, review, and approve QMS documents supporting quality objectives. You will lead validation activities, investigate nonconformances, and drive CAPAs across projects, ensuring compliance with FDA QSR and ISO13485.

Responsibilities include reviewing records, calibrations, and coordinating audits while collaborating with suppliers and cross-functional teams to maintain manufacturing quality and continuous improvement.