Senior Design Quality Engineer – MedTech

Becton Dickinson NA; Covington (GA); On-site; USD 110,000 - 150,000; Full time

Job summary

Becton, Dickinson and Company (BD) in Georgia seeks a senior Quality Engineer to provide technical leadership across quality teams. You will guide design controls, risk management, and regulatory submissions while shaping QA processes and supplier qualifications.

Role emphasizes design verification/validation, DOE, CAPA, and cross-functional collaboration to ensure robust product development and manufacturing quality in a fast-paced medical technology environment.

Qualifications

• BS in Engineering with 8+ years in Quality Engineering including design controls, product/process validation, risk management and problem solving.
• MS in Engineering with 6+ years in Quality Engineering including design controls, product/process validation, risk management and problem solving.

Responsibilities

• Provide technical leadership to Quality Engineers, Technicians, and Inspectors.
• Lead quality engineering projects to enhance quality systems, procedures and compliance.
• Develop test protocols and reports for regulatory submissions (FDA 510(k), PMA, CE).
• Support early-stage product development with quality expertise.
• Develop and maintain Risk Management Files with cross-functional teams.
• Create/execute Design Verification and Validation protocols and analyze results.
• Contribute to design control documentation (DQ, DP, DVP, DD) per BD processes.
• Coordinate external lab testing (cleaning, reprocessing validations).
• Develop inspection/test methods and plans for components and finished products.
• Support shelf-life studies and test protocols for expiration dating.
• Perform method validations and ensure data integrity.
• Lead supplier qualification, mold validation, and DOE studies.
• Support process transfers and scale-up to production.
• Review/disposition nonconforming materials/products.
• Analyze quality data to identify trends and CAPAs.
• Apply DOE and data analysis to optimize products and processes.
• Provide SME guidance across product development, pilot, manufacturing, and supplier networks.
• Mentor junior staff and support BD reliability engineering initiatives.

Skills

Quality Engineering

Design Controls

Risk Management

Statistical Methods

DOE

Gage R&R

CAPA

FDA QSR

ISO13485

Education

BS in Engineering

MS in Engineering

Job description

Becton, Dickinson and Company (BD) in Georgia seeks a senior Quality Engineer to provide technical leadership across quality teams. You will guide design controls, risk management, and regulatory submissions while shaping QA processes and supplier qualifications.

Role emphasizes design verification/validation, DOE, CAPA, and cross-functional collaboration to ensure robust product development and manufacturing quality in a fast-paced medical technology environment.