CAPA & Quality Systems Lead | Continuous Improvement

bdx; Covington (GA); On-site; USD 95,000 - 135,000; Full time

Job summary

BD is seeking a Senior Quality Systems Engineer – CAPA & Continuous Improvement to lead CAPA across the organization, driving effectiveness and compliance with regulatory requirements. You will guide investigations, action plans, and documentation while partnering with cross-functional teams to improve quality systems.

Responsibilities include data analytics, metrics reporting, and mentoring CAPA owners, with focus on continuous improvement and quality performance reporting to senior leadership.

Qualifications

• Bachelor's degree in engineering or a related technical field.
• Minimum of 6 years of engineering, quality, or quality systems experience.
• Experience with ISO 9001, ISO 13485, FDA QSR, EU MDR.
• Experience in regulated industries such as medical devices, pharmaceutical, biotechnology.
• Experience owning or managing Quality System processes, particularly CAPA.

Responsibilities

• Serve as SME for CAPA processes across the organization and drive CAPA effectiveness.
• Analyze CAPA data and develop quality metrics, dashboards, and reports for leadership.
• Lead continuous improvement initiatives to enhance quality system performance.
• Support audits, regulatory inspections, and maintain quality documentation.
• Mentor CAPA owners and project teams in investigations and CAPA requirements.

Skills

Root cause analysis

Data analysis

Excel advanced

Statistics knowledge

Data visualization

Communication

Leadership without authority

Project management

Education

Bachelor's degree in Engineering, Engineering Technology, Science

Tools

TrackWise

eQMS

CAPA management systems

Job description

BD is seeking a Senior Quality Systems Engineer – CAPA & Continuous Improvement to lead CAPA across the organization, driving effectiveness and compliance with regulatory requirements. You will guide investigations, action plans, and documentation while partnering with cross-functional teams to improve quality systems.

Responsibilities include data analytics, metrics reporting, and mentoring CAPA owners, with focus on continuous improvement and quality performance reporting to senior leadership.