Senior Quality Engineer - Medical Device, CAPA & Compliance

Becton, Dickinson and Company; Covington (GA); On-site; USD 85,000 - 110,000; Full time

Job summary

Becton, Dickinson and Company is seeking a Quality Engineer to develop, implement, and maintain quality plans ensuring compliance with FDA QSR and ISO 13485. You will support design control activities, investigate CAPA, and drive continuous improvement within a cross-functional team.

Responsibilities include audits, supplier quality management, and training across R&D, Manufacturing, and Regulatory Affairs to embed quality throughout the product lifecycle.

Qualifications

• Bachelor's degree in Chemical Engineering or related engineering discipline.
• 3 years experience in a Quality Engineering role within medical devices.
• Experience with design controls, ISO 14971 risk management, and CAPA.

Responsibilities

• Develop, implement, and maintain quality plans, procedures, and specs per FDA QSR and ISO 13485.
• Support product development through design control activities including design reviews and V&V.
• Investigate nonconformances and CAPA using root cause analysis.
• Plan and execute internal and external quality system audits.
• Collaborate with suppliers on qualification and supplier quality management.
• Analyze quality metrics and report insights to leadership.
• Lead continuous improvement via Lean, Six Sigma, and other QA tools.
• Deliver training and guidance on quality systems across cross-functional teams.
• Collaborate with R&D, Manufacturing, Regulatory Affairs to embed quality lifecycle.

Skills

Quality Engineering

Regulatory compliance

Statistical analysis

Problem solving

Cross-functional teamwork

Education

Bachelor's degree in Chemical Engineering

Tools

Minitab

SPC

FMEA

Job description

Becton, Dickinson and Company is seeking a Quality Engineer to develop, implement, and maintain quality plans ensuring compliance with FDA QSR and ISO 13485. You will support design control activities, investigate CAPA, and drive continuous improvement within a cross-functional team.

Responsibilities include audits, supplier quality management, and training across R&D, Manufacturing, and Regulatory Affairs to embed quality throughout the product lifecycle.