Senior Quality Engineer - MedTech, Design Controls & CAPA

Becton, Dickinson and Company; Covington (GA); On-site; USD 80,000 - 110,000; Full time

Job summary

Becton, Dickinson and Company in Covington, GA is seeking a Quality Engineer to develop, implement, and maintain quality plans ensuring compliance with FDA QSR and ISO 13485.

You will lead design control activities, perform risk assessments, CAPA, audits, and supplier quality management, and work with R&D, Regulatory Affairs, and Manufacturing to embed quality throughout the product lifecycle in a fast-paced medical device environment.

Qualifications

• Bachelor's degree in Chemical Engineering or related field.
• 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 and maintain quality plans, procedures, and specifications to meet FDA QSR and ISO 13485.
• Support product development through design control activities incl. design reviews and risk assessments.
• Investigate nonconformances, complaints, and deviations; drive CAPA.
• Plan and execute audits; improve quality system and supplier quality.
• Lead continuous improvement with Lean, Six Sigma; train cross-functional teams.
• Collaborate with R&D, Manufacturing, Regulatory, and others to embed quality throughout the product lifecycle.
• Support regulatory submissions and respond to inquiries as needed.

Skills

QSR compliance

CAPA processes

Statistical methods

Root cause analysis

Education

Bachelor's in Chemical Engineering

Tools

Minitab

SPC

FMEA

Job description

Becton, Dickinson and Company in Covington, GA is seeking a Quality Engineer to develop, implement, and maintain quality plans ensuring compliance with FDA QSR and ISO 13485.

You will lead design control activities, perform risk assessments, CAPA, audits, and supplier quality management, and work with R&D, Regulatory Affairs, and Manufacturing to embed quality throughout the product lifecycle in a fast-paced medical device environment.