Senior Quality Engineer — MedTech, On-Site Impact Leader

Becton, Dickinson and Company (BD); Covington (VA); On-site; USD 80,000 - 105,000; Full time

Job summary

Becton, Dickinson and Company (BD) is seeking a Quality Engineer to develop and maintain quality plans and ensure compliance with FDA QSR, ISO 13485, and CAPA processes. You will drive design controls, risk assessments, and supplier quality oversight within a fast-paced medical device environment.

Join BD’s team to collaborate across R&D, manufacturing, and regulatory affairs, delivering training and leading continuous improvement initiatives, while embedding quality throughout the product

Qualifications

• Bachelor's degree in Chemical Engineering or closely related engineering field.
• 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 regulatory compliance (FDA QSR, ISO 13485).
• Support product development through design control activities including design reviews, risk assessments, and verification/validation testing.
• Investigate quality issues and CAPA implementation using root cause analysis.
• Plan and perform internal and external audits to assess quality system compliance.
• Collaborate with suppliers on qualification, performance monitoring, and supplier quality.
• Analyze quality metrics and communicate insights to leadership.
• Lead continuous improvement initiatives using Lean, Six Sigma, and other quality tools.
• Deliver training and guidance on quality systems and regulatory requirements.

Skills

Quality engineering

CAPA

Design controls

FDA QSR

ISO 14971

Statistics (Minitab)

Problem solving

Communication

Education

Bachelor's degree 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 and ensure compliance with FDA QSR, ISO 13485, and CAPA processes. You will drive design controls, risk assessments, and supplier quality oversight within a fast-paced medical device environment.

Join BD’s team to collaborate across R&D, manufacturing, and regulatory affairs, delivering training and leading continuous improvement initiatives, while embedding quality throughout the product