Quality Engineer, MedTech CAPA & Validation Lead

Regulatory Jobs; Delran Township (NJ); On-site; USD 84,000 - 134,000; Full time

Benefits offered by this job

Annual Bonus

Health and Well-being Benefits

Career development support

Job summary

BD in Delran, NJ, is hiring a Quality Engineer to author, review, and approve QMS documents and records, supporting BD Delran plant quality objectives. You will act as the quality representative on project teams, drive CAPAs, NCRs, MRB processes, and ensure customer requirements align with quality standards.

The role requires a Bachelor’s degree in Biomedical/Engineering and 3 years in medical devices manufacturing in a QE capacity.

Qualifications

• Bachelor’s Degree in Biomedical/ Engineering or related field.
• 3 years experience in medical devices and/or manufacturing environment, in a Quality Engineering role or equivalent.

Responsibilities

• Lead validation activities, including authoring and executing protocols to support new product development, process improvements, equipment changes, and test method validations.
• Provide technical and quality engineering support for ongoing manufacturing and sustaining projects.
• Design and conduct quality engineering studies to identify root causes of nonconformances and drive improvements in processes, tooling, and product design.
• Lead investigations into quality issues, initiate NCRs, and manage MRB processes.
• Develop and maintain quality documentation, including inspection plans, test methods, quality standards, and QC inspection procedures.
• Review and approve inspection records and environmental monitoring data to ensure compliance with quality requirements.
• Review Lot History Records for accuracy and regulatory compliance.
• Review customer specifications and product requirements to ensure alignment with quality expectations.
• Investigate customer complaints, determine root causes, and support corrective and preventive actions.
• Coordinate calibration activities for measuring equipment to maintain accuracy.
• Participate in audits and regulatory inspections to support compliance and continuous improvement.

Skills

Quality engineering

Statistical analysis

Quality systems

Education

Bachelor's degree in Biomedical/Engineering

Tools

Minitab

MS Excel

Job description

BD in Delran, NJ, is hiring a Quality Engineer to author, review, and approve QMS documents and records, supporting BD Delran plant quality objectives. You will act as the quality representative on project teams, drive CAPAs, NCRs, MRB processes, and ensure customer requirements align with quality standards.

The role requires a Bachelor’s degree in Biomedical/Engineering and 3 years in medical devices manufacturing in a QE capacity.