Senior Quality Engineer, MedTech: Design Controls & CAPA

BD; Covington (FL); On-site; USD 75,000 - 95,000; Full time

Job summary

BD is a leading global medical technology company seeking a Quality Engineer to develop and maintain quality plans, ensuring FDA QSR and ISO 13485 compliance throughout the product lifecycle at the Covington, GA site.

You will lead design controls, risk assessments, CAPA, audits, supplier quality, and data-driven improvement, collaborating with R&D, Manufacturing, Regulatory Affairs and other functions. A Bachelor's in Engineering and 3 years of medical device quality experience are required.

Qualifications

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

Responsibilities

• Develop, implement, and maintain quality plans, procedures, and specs to ensure FDA QSR/ISO 13485 compliance.
• Support product development through design controls, risk assessments, and verification/validation testing.
• Investigate nonconformances, customer complaints, and deviations using root cause analysis and CAPA.
• Plan and execute internal and external audits to evaluate quality system compliance.
• Partner with suppliers on qualification, performance monitoring, and supplier quality management.
• Analyze quality metrics, prepare reports, and communicate insights to leadership.
• Lead continuous improvement initiatives using Lean, Six Sigma, and other quality tools.
• Deliver training and guidance on quality systems and compliance to cross-functional teams.
• Collaborate with R&D, Manufacturing, Regulatory Affairs to embed quality across the product lifecycle.
• Support regulatory submissions and respond to inquiries as needed.

Skills

FDA QSR compliance

ISO 13485

CAPA process

Design controls

Risk management ISO 14971

Minitab

SPC

FMEA

Statistical analysis

Cross-functional collaboration

Education

Bachelor's degree in Chemical Engineering or related engineering

Tools

Minitab

SPC

FMEA

Job description

BD is a leading global medical technology company seeking a Quality Engineer to develop and maintain quality plans, ensuring FDA QSR and ISO 13485 compliance throughout the product lifecycle at the Covington, GA site.

You will lead design controls, risk assessments, CAPA, audits, supplier quality, and data-driven improvement, collaborating with R&D, Manufacturing, Regulatory Affairs and other functions. A Bachelor's in Engineering and 3 years of medical device quality experience are required.