Senior MedTech Quality Engineer - Design Controls & CAPA

BD; Covington (GA); On-site; USD 90,000 - 125,000; Full time

Benefits offered by this job

On-site work

Vaccination policy

Equal Opportunity Employer

Job summary

BD is a leading global medical technology company seeking a Quality Engineer to ensure product quality and regulatory compliance across the lifecycle. You will work with R&D, Manufacturing, Regulatory Affairs, and suppliers to embed quality throughout design, development, and production.

Responsibilities include CAPA, audits, data analysis, and continuous improvement using Lean/Six Sigma methodologies. On-site collaboration is emphasized, with a focus on regulatory readiness and patient safety.

Qualifications

• Bachelor's degree in Engineering or related field required.
• 3+ years in a Quality Engineering role within the medical device industry preferred.
• Experience with design controls, ISO 14971, and CAPA processes desired.

Responsibilities

• Develop, implement, and maintain quality plans, procedures, and specifications to ensure regulatory compliance (FDA QSR and ISO 13485).
• Support product development through design control activities, risk assessments, and verification/validation testing to ensure quality and safety.
• Investigate nonconformances, customer complaints, and deviations using root cause analysis and drive CAPA closures.
• Plan and conduct internal and external quality audits to ensure compliance and identify improvements.
• Collaborate with suppliers on qualification, performance monitoring, and supplier quality management.
• Analyze quality metrics, prepare reports, and communicate insights to leadership.
• Lead Lean, Six Sigma, and continuous improvement initiatives across teams.
• Provide training and guidance on quality systems and regulatory requirements.

Skills

Quality engineering

Design controls

CAPA

ISO 13485

Statistical analysis

FMEA

Regulatory compliance

Cross-functional collaboration

Education

Bachelor's degree in engineering

Tools

Minitab

SPC

Job description

BD is a leading global medical technology company seeking a Quality Engineer to ensure product quality and regulatory compliance across the lifecycle. You will work with R&D, Manufacturing, Regulatory Affairs, and suppliers to embed quality throughout design, development, and production.

Responsibilities include CAPA, audits, data analysis, and continuous improvement using Lean/Six Sigma methodologies. On-site collaboration is emphasized, with a focus on regulatory readiness and patient safety.