Lead Design Quality Engineer - MedTech Innovator

BD; Covington (GA); On-site; USD 115,000 - 160,000; Full time

Job summary

BD is seeking a senior Quality Engineer to provide technical leadership across quality teams and guide regulatory submissions. You will drive design controls, risk management, and process validation to ensure compliance with 21 CFR 820, ISO 13485, and related standards.

Role requires strong expertise in QA methodologies, data analysis, and cross-functional collaboration to support manufacturing and supplier networks. This position is based in Covington, GA with on-site requirements.

Qualifications

• BS with 8+ years in quality engineering; design controls, validation, risk management, problem solving.
• MS with 6+ years in quality engineering; design controls, validation, and regulatory knowledge.

Responsibilities

• Provide technical leadership toQuality Engineers,Technicians, and Inspectors.
• Lead quality projects to improve systems, procedures, and compliance.
• Develop test protocols and reports for FDA/CE submissions.
• Support pre-concept and front-end development with quality expertise.
• Develop and maintain Risk Management Files across cross-functional teams.
• Create and execute Design Verification/Validation protocols and analyses.

Skills

Quality Engineering

Design Controls

Statistical Methods

Six Sigma

FDA QSR

ISO 13485

ISO 9001

Process Validation

Education

Bachelor's degree in a related field

Master's degree in related field

Tools

None

Job description

BD is seeking a senior Quality Engineer to provide technical leadership across quality teams and guide regulatory submissions. You will drive design controls, risk management, and process validation to ensure compliance with 21 CFR 820, ISO 13485, and related standards.

Role requires strong expertise in QA methodologies, data analysis, and cross-functional collaboration to support manufacturing and supplier networks. This position is based in Covington, GA with on-site requirements.