Senior Quality Engineer - MedTech, CAPA & Compliance

Regulatory Jobs; Covington (GA); Presencial; USD 80.000 - 110.000; Jornada completa

Descripción de la vacante

BD strives to improve global health through quality and innovation. We are seeking a Quality Engineer in Covington, GA to develop and maintain quality plans, support design controls, and drive CAPA across the product lifecycle.

You will collaborate with R&D, Manufacturing and Regulatory Affairs to embed quality, participate in audits, and ensure compliance with FDA QSR and ISO 13485. If you are passionate about rigorous quality systems and Lean Six Sigma, join BD to help deliver safer, better

Formación

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

Responsabilidades

• Develop, implement, and maintain quality plans, procedures, and specs to ensure regulatory compliance (FDA QSR, ISO 13485).
• Support product development through design control activities, risk assessments, and verification/validation testing.
• Investigate nonconformances, customer complaints, and deviations using root cause analysis and drive CAPA.
• Plan and execute internal and external audits to evaluate quality system compliance.
• Partner with suppliers for qualification, performance monitoring, and supplier quality management.

Conocimientos

Quality engineering

FDA QSR

ISO 13485

CAPA

Design controls

Risk assessment

Root cause analysis

Statistical tools

Educación

Bachelor's degree in Chemical Engineering

Herramientas

Minitab

FMEA

SPC

Descripción del empleo

BD strives to improve global health through quality and innovation. We are seeking a Quality Engineer in Covington, GA to develop and maintain quality plans, support design controls, and drive CAPA across the product lifecycle.

You will collaborate with R&D, Manufacturing and Regulatory Affairs to embed quality, participate in audits, and ensure compliance with FDA QSR and ISO 13485. If you are passionate about rigorous quality systems and Lean Six Sigma, join BD to help deliver safer, better