Senior Quality Engineer, Medical Devices — On‑Site

BD; Covington (GA); On-site; USD 85,000 - 110,000; Full time

Job summary

BD in Covington, GA is seeking a Quality Engineer to develop, implement, and maintain quality plans ensuring regulatory compliance (FDA QSR, ISO 13485) across the product lifecycle.

You will lead design controls, CAPA, audits, supplier quality, data analysis, and cross-functional collaboration with R&D, Manufacturing, and Regulatory Affairs; on-site presence required four days per week.

Qualifications

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

Responsibilities

• Develop, implement, and maintain quality plans and procedures to ensure regulatory compliance.
• Support product development with design controls, risk assessments, and verification/validation.
• Investigate nonconformances and CAPA, lead internal/external audits, and drive improvements.
• Collaborate with R&D, Manufacturing, Regulatory Affairs and suppliers throughout the lifecycle.

Skills

Quality engineering

Regulatory compliance

Root cause analysis

Analytical thinking

Cross-functional collaboration

Education

Bachelor's degree in Chemical Engineering

Tools

Minitab

SPC

FMEA

Job description

BD in Covington, GA is seeking a Quality Engineer to develop, implement, and maintain quality plans ensuring regulatory compliance (FDA QSR, ISO 13485) across the product lifecycle.

You will lead design controls, CAPA, audits, supplier quality, data analysis, and cross-functional collaboration with R&D, Manufacturing, and Regulatory Affairs; on-site presence required four days per week.