Senior Design Quality Engineer: Drive Patient-Safe MedTech

Becton Dickinson NA; Covington (GA); On-site; USD 110,000 - 165,000; Full time

Job summary

Becton, Dickinson and Company (BD) is hiring a Senior Design Quality Engineer in Covington, GA. The role guards product quality from design through commercialization, partnering with manufacturing, engineering and suppliers to uphold safety and regulatory standards.

You will lead design control, risk assessments, and quality initiatives while mentoring staff and driving continuous improvement in a fast-paced medical device environment.

Qualifications

• Bachelor's Degree in Engineering or higher with 4+ years in quality engineering in a regulated environment.
• Master's Degree with 2+ years in quality engineering in a regulated environment.
• Experience leading design control, document control and QA in medical device development.

Responsibilities

• Provide QA leadership across the product lifecycle and own design controls for the product line.
• Collaborate with contract manufacturers and internal plants to implement changes while maintaining quality.
• Lead risk assessment activities including FMEA, FMECA and fault tree analyses.
• Develop and maintain Design History Files, CAPAs, and audit reports.
• Ensure protocols for process/product validation and stability studies are approved.
• Mentor technicians and engineers to build a stronger quality organization.

Skills

Quality Leadership

Design Control

Risk Management

Regulatory Knowledge

Cross-functional Collaboration

Statistical Analysis

Mentoring

Education

Bachelor's Degree in Engineering

Master's Degree

Tools

CAPA Systems

FMEA Tools

FDA/MDSAP Knowledge

Job description

Becton, Dickinson and Company (BD) is hiring a Senior Design Quality Engineer in Covington, GA. The role guards product quality from design through commercialization, partnering with manufacturing, engineering and suppliers to uphold safety and regulatory standards.

You will lead design control, risk assessments, and quality initiatives while mentoring staff and driving continuous improvement in a fast-paced medical device environment.