Senior Quality Engineer, MedTech | CAPA & Design Controls

Becton Dickinson; Covington (GA); On-site; USD 75,000 - 110,000; Full time

Job summary

Becton, Dickinson, and Company (BD) is seeking a Quality Engineer to develop and maintain quality plans, ensure regulatory compliance, and lead CAPA efforts across design, manufacturing, and supplier quality teams. The role emphasizes data-driven decision making and collaboration with R&D, Regulatory, and Manufacturing to deliver safe, effective medical devices.

The position requires 3+ years in quality engineering within medical devices, knowledge of ISO 14971, and experience with design

Qualifications

• Bachelor's degree in Chemical Engineering or closely related engineering disciplines.
• 3 years of experience in a Quality Engineering role within the medical device industry.
• Demonstrated experience with design controls, risk management (ISO 14971), and CAPA processes.

Responsibilities

• Develop, implement, and maintain quality plans, procedures, and specifications to ensure compliance with regulatory requirements and industry standards (FDA QSR and ISO 13485).
• Support product development through design control activities such as design reviews, risk assessments, and verification and validation testing to ensure product quality, safety, and effectiveness.
• Investigate product nonconformances, customer complaints, and manufacturing deviations using root cause analysis methodologies, and drive CAPA.
• Plan and execute internal and external audits to evaluate quality system compliance and identify opportunities for continuous improvement.
• Collaborate with suppliers to support qualification, performance monitoring, and ongoing supplier quality management.

Skills

Chemical processes

Materials

Statistical analysis

Problem-solving

Education

Bachelor's in Chemical Engineering

Tools

Minitab

SPC

FMEA

Job description

Becton, Dickinson, and Company (BD) is seeking a Quality Engineer to develop and maintain quality plans, ensure regulatory compliance, and lead CAPA efforts across design, manufacturing, and supplier quality teams. The role emphasizes data-driven decision making and collaboration with R&D, Regulatory, and Manufacturing to deliver safe, effective medical devices.

The position requires 3+ years in quality engineering within medical devices, knowledge of ISO 14971, and experience with design